Summary
Overview
Work History
Education
Skills
Timeline
Generic

CARMEL ANDREWS

Marietta

Summary

Results-driven Quality Assurance Lead Lab Technician ready for a new position where my talents can be properly utilized. Capable of testing samples, maintaining all recordkeeping systems and calibrating and troubleshooting most medical equipment. Offering over 15 years of hands-on experience in the Medical device industry from Siemens and Idexx Labs.

Quality-focused professional, prepared to ensure top-notch standards in quality assurance and control. Brings valuable experience in streamlining processes and maintaining compliance. Known for team collaboration and adaptability to changing needs, with expertise in quality assessments and regulatory standards.

Experienced with quality control processes and methodologies. Utilizes problem-solving skills to enhance operational efficiency. Strong understanding of compliance protocols and quality management systems.

Overview

24
24
years of professional experience

Work History

Lab Quality Associate SR/ WoundCare Manufacturing Processor

ProgenaCare
11.2022 - Current
  • Performs duties as assigned
  • Prepare solutions
  • Set up equipment and follow SOPs
  • Operate all production lab equipment
  • Perform daily cleaning and sanitation laboratories and equipment
  • Perform Assays and Maintaining accurate and detailed sample
  • Packing all product and ship for Sterilization
  • Improved product quality by implementing rigorous inspection processes and providing feedback to production teams.
  • Enhanced customer satisfaction by addressing and resolving complaints in a timely manner.
  • Trained new Quality Associates on company policies, procedures, and best practices to ensure consistent performance across the team.
  • Conducted thorough root cause analyses for non-conformances, contributing to continuous improvement initiatives.
  • Supported the development of a positive quality culture within the organization through continuous education and communication efforts.
  • Maintained open lines of communication with regulatory agencies, ensuring the organization remained in compliance with all applicable standards and industry regulations.
  • Implemented process improvements based on data analysis, resulting in reduced defect rates and increased overall product quality.
  • Performed routine equipment calibrations, ensuring accurate measurements were obtained consistently throughout testing processes.
  • Contributed to successful ISO certification renewals by maintaining up-to-date documentation and demonstrating compliance during external audits.
  • Reduced production downtime by identifying potential issues early and working with cross-functional teams to implement corrective actions.
  • Developed comprehensive reports detailing quality metrics, trends, and recommendations for management review.
  • Championed Lean Six Sigma initiatives within the department, driving waste reduction efforts through process optimization and standardization techniques.
  • Collaborated with manufacturing teams to optimize production processes for improved quality and efficiency.
  • Actively participated in cross-functional problem-solving sessions, leveraging expertise in quality principles as well as strong analytical skills.
  • Streamlined quality control procedures by developing and implementing standardized checklists for consistent inspections.
  • Maintained accurate records of all quality-related activities, ensuring compliance with regulatory requirements.
  • Participated in internal audits to identify areas for improvement and ensure adherence to established procedures.
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Educated employees on specific QA standards and confirmed maintenance of standards.
  • Examined products for imperfections and defects.
  • Followed standard operating procedures for inspections and tests.
  • Recorded inspection and test results on data sheets.
  • Monitored product quality at all stages of production process.
  • Updated quality control records and reports.
  • Checked color, shape, texture and grade of products and materials against established templates, charts, and samples.
  • Followed safety protocols while handling hazardous materials.
  • Operated and maintained testing equipment.
  • Provided feedback to production team regarding product quality.
  • Sampled products to verify compliance with standards
  • Assisted in developing inspection and testing protocols.
  • Repaired faults, reassembled products, and completed additional tests.
  • Utilized quality control software to track and analyze product data.
  • Investigated customer complaints to take necessary corrective actions.
  • Used analyzers, multimeters and power supplies to conduct diagnostic procedures.
  • Supported team members in their tasks, contributing to overall team success.
  • Increased productivity by effectively managing workload and prioritizing tasks.
  • Enhanced team collaboration, sharing best practices for efficient processing techniques.
  • Received and reviewed incoming documents and materials.
  • Maintained accurate records and ensured timely completion of all necessary paperwork.
  • Assisted colleagues as needed, fostering a positive work environment based on teamwork and mutual supportiveness.
  • Participated in continuous training initiatives, staying up-to-date on relevant regulations, policies, and best practices within the processing field.
  • Provided outstanding customer service by promptly addressing inquiries and resolving issues.
  • Adhered to strict deadlines for processing applications, ensuring timely approvals and client satisfaction.
  • Demonstrated flexibility when adapting to new processes or guidelines while maintaining consistently high levels of productivity.
  • Reduced errors with meticulous attention to detail and thorough review of documentation.
  • Developed expertise in various processing systems for increased efficiency and accuracy.
  • Collaborated with cross-functional teams to ensure smooth handoffs and timely completion of projects.
  • Contributed to the achievement of department goals through consistent high-quality work.
  • Utilized strong analytical skills to identify potential risks or discrepancies within processed documents quickly.
  • Managed multiple priorities simultaneously, maintaining organization even during peak periods.
  • Mastered industry-specific software tools to expedite data entry tasks and reduce manual input errors.
  • Implemented new workflows to streamline the processor role, resulting in improved performance metrics.
  • Streamlined data processing workflows, significantly reducing processing times.
  • Maintained high levels of data security by adhering to strict data protection policies.
  • Facilitated cross-departmental collaboration to improve overall processing efficiency.
  • Analyzed processing bottlenecks and devised strategies to eliminate them.
  • Conducted regular performance evaluations, identifying areas for improvement in processing operations.
  • Oversaw transition to new processing system, minimizing downtime and maintaining productivity.
  • Reduced error rates in data entry by conducting thorough training sessions for new hires.
  • Led team project to overhaul outdated processing procedures, resulting in more efficient workflow.
  • Improved client satisfaction by ensuring timely and accurate processing of requests.
  • Developed comprehensive training program for processing staff, elevating team expertise.
  • Implemented tracking system for processing tasks to ensure accountability and timely completion.
  • Engaged in continuous professional development to stay updated on latest processing technologies.
  • Increased team productivity with introduction of automated processing tools.
  • Maintained organized work area by cleaning and removing hazards.
  • Made sure that products were produced on time and are of good quality.
  • Used problem-solving and issue-resolution skills to promptly and successfully address production problems.
  • Examined incoming materials and compared to documentation for accuracy and quality.
  • Prepared reports and technical documentation of day-to-day production processes.
  • Organized and prepared workstations and materials needed for operations to maximize productivity.
  • Calibrated machines to maintain required productivity levels and adherence to quality standards.
  • Met production targets and tight deadlines by collaborating closely with team members.
  • Inspected products and machines to maintain quality and efficiency.
  • Performed general equipment maintenance and repair to minimize downtime.

Quality Control Inspector

Roytec Industries
03.2024 - 02.2025
  • Communicated with production team members about quality issues.
  • Inspected quality of products, taking note of functionality, appearance and other specifications.
  • Inspected incoming and outgoing materials for accuracy and quality.
  • Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
  • Performed visual inspections and non-destructive tests where appropriate.
  • Improved product quality by conducting thorough inspections and identifying defects in a timely manner.
  • Maintained compliance with industry regulations through meticulous record-keeping and documentation of inspection results.
  • Collaborated with production staff to establish and meet quality standards
  • Evaluated components and final products against quality standards and manufacturing specifications.
  • Completed precise measurements using special tools.
  • Participated in team meetings to discuss progress and results, providing ideas and suggestions for improvement.
  • Identified and documented quality discrepancies for management to develop resolutions.
  • Reduced product rejection rates by collaborating with production teams to address quality issues proactively.
  • Ensured the accuracy of measurement tools and equipment by performing regular calibration checks and maintenance.
  • Actively participated in regular audits to verify compliance with industry regulations and company policies, ensuring continued certification and enhanced credibility within the market.
  • Investigated customer complaints related to product quality, working closely with manufacturing teams to resolve concerns swiftly.
  • Enhanced production efficiency by implementing standardized inspection processes and procedures.
  • Improved production processes with thorough analysis and feedback, leading to more efficient operations.
  • Reduced waste by implementing stricter quality control measures during manufacturing process.
  • Updated quality control records and reports.
  • Examined products for imperfections and defects.
  • Monitored product quality at all stages of production process.
  • Followed standard operating procedures for inspections and tests.
  • Recorded inspection and test results on data sheets.
  • Provided feedback to production team regarding product quality.
  • Sampled products to verify compliance with standards
  • Operated and maintained testing equipment.
  • Followed safety protocols while handling hazardous materials.
  • Assisted in developing inspection and testing protocols.
  • Repaired faults, reassembled products, and completed additional tests.
  • Weighed products prior to shipment to confirm accuracy.
  • Utilized quality control software to track and analyze product data.

Lead Lab Quality Associate SR

IDEXX Laboratories Inc.
11.2008 - 11.2022
  • Perform inspection, analysis and test to specification, requirements and industry standards, using specialized instruments
  • Performing high level of testing which included manipulating human and animal blood and plasma for testing with minimal error
  • Complete related documentation, paperwork, and data entry
  • Collect and provide reports
  • Analyze testing and report data
  • Maintain current procedures, SOPs and 5S standards to meet FDA and OSHA standards
  • Manage a team of 5 lab assistants
  • Manage special handling requirements for hazardous material as needed
  • Take responsibility and authority for ensuring quality assurance compliance throughout affected areas
  • Complete quality assurance record reviews on all associated medical, blood, plasma and distribution records
  • Review all associated monitoring records for medical device and tissue related departments
  • Maintain all quality assurance records per current requirements
  • Interface with other departments to clarify and/or correct information provided and solicit information as required
  • Develop systematic methods for completing work assignments to ensure deadlines are met and personal job commitments are accomplished
  • Understand ISO requirements, GTPs, and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance, blood and plasma/product storage and identification, etc
  • Keep supervisors and associates informed of significant information, company policies and procedures as they become available, and provide such information in a manner that encourages willing cooperation and support
  • Provide input to management that facilitates the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job
  • Increase productivity and revenues by optimizing processes, work flows, and manufacturing equipment
  • Trained in 6S Lean, Sig Sigma Lean Belt Training
  • Trained in real and mock FDA QSR(21 CRF 820) ISO 13485 and OSHA audits and cGMP
  • Proficient in CAPA Action, RMQ(Raw Material Qualifications, NCMR’s for Non-Conformance Final Dispositions Change Orders and Project PQ Deviations and Creating First Article and COA Certificates
  • Improved product quality by implementing rigorous inspection processes and providing feedback to production teams.
  • Enhanced customer satisfaction by addressing and resolving complaints in a timely manner.
  • Actively participated in cross-functional problem-solving sessions, leveraging expertise in quality principles as well as strong analytical skills.
  • Participated in internal audits to identify areas for improvement and ensure adherence to established procedures.
  • Coordinated with engineering teams on design changes, providing input on potential impact to product functionality or manufacturability.
  • Maintained accurate records of all quality-related activities, ensuring compliance with regulatory requirements.
  • Implemented process improvements based on data analysis, resulting in reduced defect rates and increased overall product quality.
  • Maintained open lines of communication with regulatory agencies, ensuring the organization remained in compliance with all applicable standards and industry regulations.
  • Championed Lean Six Sigma initiatives within the department, driving waste reduction efforts through process optimization and standardization techniques.
  • Conducted thorough root cause analyses for non-conformances, contributing to continuous improvement initiatives.
  • Streamlined quality control procedures by developing and implementing standardized checklists for consistent inspections.
  • Trained new Quality Associates on company policies, procedures, and best practices to ensure consistent performance across the team.
  • Contributed to successful ISO certification renewals by maintaining up-to-date documentation and demonstrating compliance during external audits.
  • Supported the development of a positive quality culture within the organization through continuous education and communication efforts.
  • Developed comprehensive reports detailing quality metrics, trends, and recommendations for management review.
  • Educated employees on specific QA standards and confirmed maintenance of standards.
  • Utilized quality control software to track and analyze product data.
  • Used analyzers, multimeters and power supplies to conduct diagnostic procedures.

Quality Control III

JVC
09.2006 - 10.2008
  • Conducted spontaneous inspections on work processes and 25 RW equipment, helping to reduce job site incident rates by 85% in 3 months
  • Ensured 320 employees had 24/7 access to quality assurance information by training them on how to use a QA software app, improving employee knowledge by 65%
  • Trained current staff on quality assurance regulation, strengthening overall corporate QA capabilities by 45%
  • Performed visual inspections using a micrometer, and caliper to inspect 83 machines twice daily for 16 months, ensuring parts worked perfectly
  • Inspecting and doing first article on all finished goods and raw materials
  • Self-motivated, with a strong sense of personal responsibility.
  • Worked effectively in fast-paced environments.
  • Worked well in a team setting, providing support and guidance.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Organized and detail-oriented with a strong work ethic.
  • Paid attention to detail while completing assignments.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Strengthened communication skills through regular interactions with others.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Developed and maintained courteous and effective working relationships.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Learned and adapted quickly to new technology and software applications.

Quality Assurance Lead

Siemens
01.2001 - 10.2008
  • Administered all operations in Quality lab
  • Taught a team of 10 and supported the training of technicians and supervised their research
  • Checked the different parameters of the raw and finished products sent for different companies and analyze the data
  • Ensured quality control/ quality assurance of data and prepared reagents for testing
  • Mentored junior team members in quality assurance best practices, fostering a culture of continuous improvement.
  • Implemented continuous improvement initiatives within the QA team to elevate performance levels consistently across projects over time.
  • Collaborated with cross-functional teams to ensure seamless integration of QA efforts into product development lifecycle.
  • Performed internal audits to maintain operating procedure and regulatory standards compliance.
  • Identified process gaps and implemented corrective actions, resulting in higher efficiency and reduced error rates.
  • Improved customer satisfaction with high-quality products through meticulous QA processes.
  • Coached and motivated [Number]-person QA team to develop competencies.
  • Acted as key point of contact for all QA aspects of releases by providing QA services and coordinating QA resources internally and externally.
  • Delivered timely and accurate reports on test results, facilitating informed decision-making for product improvements.
  • Evaluated new testing tools and technologies, making recommendations for adoption when appropriate to enhance overall QA capabilities.
  • Managed testing initiatives, establishing metrics, standards, methodology and necessary testing precautions and scheduling execution.
  • Streamlined the QA workflow by automating repetitive tasks, increasing overall efficiency.
  • Communicated directly with QA team to resolve user-reported problems and questions.
  • Led root cause analysis efforts for major defects, preventing reoccurrence and improving overall product stability.
  • Recommended software solutions such as automated test tools or improved test processes to meet business strategies.
  • Directed day-to-day quality assurance department activities, establishing rapport with team members to facilitate effective communication and coordination.
  • Performed regression tests following bug fixes or software updates, verifying the absence of unintended side effects from changes made to the system.
  • Designed test plans based on project requirements, ensuring comprehensive validation of functionality according to specifications.
  • Enhanced product quality by implementing rigorous testing procedures and protocols.
  • Established and updated QA processes and metrics in line with industry best practices and project goals.
  • Investigated variances, performed root-cause analysis and documented corrective actions to resolve complications.
  • Enforced compliance with federal, state, local and internal regulations related to product quality and operational activities.
  • Used SQL to validate test results and recommend corrective actions.
  • Wrote, reviewed and approved documents to preserve quality assurance.
  • Created detailed defect reports for clear communication between development teams about identified bugs.
  • Managed test case creation and execution to ensure comprehensive coverage of all feature sets.
  • Coordinated with developers to troubleshoot issues discovered during testing, expediting resolution times and minimizing delays in product release schedules.
  • Identified needed test resources and worked within budget restrictions to coordinate procurement.
  • Established metrics, applied industry best practices and developed new tools and processes.
  • Created requirements for milestones and monitored completion of tasks for QA team.
  • Developed a risk-based testing approach that prioritized critical areas, optimizing resource allocation and ensuring maximum impact.
  • Conducted regular audits of testing environments to maintain accuracy and consistency across all test scenarios.
  • Analyzed quality management system metrics to identify trends, lead improvement projects and prepare third-party inspections and audits.
  • Established performance benchmarks to measure the success of QA initiatives, driving further enhancements over time.
  • Updated training database to help resolve common issues.
  • Identified potential product risks and developed plans to mitigate or eliminate hazards.
  • Supported development of materials, aids and curriculum to direct staff in procedures and operations.
  • Reduced software defects by conducting thorough code reviews and debugging sessions.

Education

Natural Arts - Natural Arts

American InterContinental
Dunwoody, GA
01-2005

Associate of Science - Nutrition

Auburn University
Auburn, AL
01.1999

Associate of Science - Chemistry

Florida Tech
Melbourne, FL
01.1997

Skills

  • Ability to read, interpret and carry out detailed instructions
  • Ability to operate complex measurement instruments
  • Ability to determine proper measurement methods
  • Ability to read and comprehend correspondence, memos, and SOPs
  • Ability to present information effectively
  • Advanced math skills
  • Ability to work with units of measure
  • Problem solving skills
  • Managing ISO and FDA Audits
  • Good PC skills
  • MS Office
  • SAP
  • JMP
  • Quality training
  • Quality management system
  • CAPA management
  • 5S methodology
  • Quality metrics
  • Documentation review
  • Standard work
  • Supplier quality
  • Product inspection
  • Non-conformance reporting
  • Visual management
  • Process validation
  • Internal auditing
  • Waste reduction
  • Kaizen events
  • Sampling plans
  • Change control
  • Corrective action
  • Control charts
  • Validation protocols
  • Value stream mapping
  • Overall equipment effectiveness
  • GMP compliance
  • Measurement systems analysis
  • Flow optimization
  • Problem-solving skills
  • Team collaboration
  • Team leadership
  • Manual testing
  • Verbal and written communication
  • Decision-making
  • Detail-oriented
  • Safety procedures
  • Functional testing
  • Quality improvements
  • Analytical thinking
  • Quality management systems
  • Regression testing
  • Public speaking
  • Documentation and reporting
  • Issue resolution
  • Quality assurance
  • Project management
  • Data analysis
  • Materials inspection
  • Performance monitoring
  • Risk management
  • German fluency
  • Non-compliance assessments
  • Quality system implementation
  • Defect tracking
  • Sampling

Timeline

Quality Control Inspector

Roytec Industries
03.2024 - 02.2025

Lab Quality Associate SR/ WoundCare Manufacturing Processor

ProgenaCare
11.2022 - Current

Lead Lab Quality Associate SR

IDEXX Laboratories Inc.
11.2008 - 11.2022

Quality Control III

JVC
09.2006 - 10.2008

Quality Assurance Lead

Siemens
01.2001 - 10.2008

Associate of Science - Nutrition

Auburn University

Natural Arts - Natural Arts

American InterContinental

Associate of Science - Chemistry

Florida Tech

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