Sarah Moore
Winona Lake,IN
Summary
Accomplished in enhancing quality assurance processes and leading cross-functional teams, my tenure at DePuy Synthes Joint Reconstruction showcases a strong foundation in regulatory compliance and continuous improvement initiatives. Leveraging expertise in quality management systems and team leadership, I've driven significant advancements in product reliability and customer satisfaction.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Senior Quality Engineer
Red Star Contract Manufacturing
10.2023 - Current
- Drove standardization efforts to ensure consistent product output meeting stringent specifications.
- Developed comprehensive quality assurance plans, ensuring compliance with industry standards and regulations.
- Served as liaison between engineering, manufacturing, and customers to address concerns regarding product quality or performance issues.
- Facilitated training sessions on various topics including statistical process control techniques, lean principles, or problem-solving methodologies for enhancing employee competencies within the organization.
- Enhanced customer satisfaction with thorough root cause analysis and timely resolution of complaints.
- Implemented effective corrective action plans based on thorough data analysis and investigation findings.
- Influenced supplier selection criteria by evaluating their capability to meet desired specifications consistently over time.
- Conducted regular audits of suppliers and vendors to maintain high-quality supply chain management.
- Managed risk assessments to identify potential hazards and implement corrective actions for continuous improvement.
- Created detailed reports analyzing trends in product performance, identifying areas for enhancement or improvement.
- Mentored junior engineers on best practices in quality engineering, fostering a culture of excellence within the team.
- Provided technical support in resolving complex quality issues by conducting thorough investigations and presenting data-driven recommendations.
- Contributed to root cause analysis to determine core reason for failures and errors.
- Collaborated with other departments to facilitate successful project completion.
- Created detailed reports on engineering activities and findings.
- Trained and mentored junior engineers, providing guidance and direction.
- Developed and implemented procedures to verify compliance with engineering standards.
- Analyzed and interpreted data to identify trends and recommend improvements.
- Conducted research to identify and evaluate new technologies and concepts.
Senior Quality Systems Engineer
Avalign Technologies
05.2023 - 10.2023
- Enhanced quality assurance processes, collaborating with cross-functional teams to identify and resolve system inefficiencies.
- Developed testing protocols for reducing product defects and ensuring compliance with industry standards.
- Improved product reliability by analyzing failure data and implementing corrective actions.
- Conducted root cause analysis to identify process improvement opportunities and prevent recurrence of issues.
- Implemented quality management systems to ensure consistency and high standards in production.
- Improved customer satisfaction by addressing quality concerns and implementing effective solutions.
- Developed training programs for staff to ensure adherence to quality standards.
- Analyzed quality data to drive continuous improvement initiatives.
- Exceeded quality benchmarks, maintaining rigorous standards for product excellence.
- Facilitated implementation of corrective action plans to address non-conformance issues.
- Improved supplier quality management by developing robust evaluation and feedback systems.
- Led cross-departmental teams to drive quality improvements and achieve company objectives.
- Led training initiatives for staff on quality system processes, resulting in increased understanding and adherence to established procedures.
- Conducted root cause analysis to identify areas for improvement, leading to a reduction in product defects.
- Developed and implemented comprehensive quality control procedures, ensuring compliance with industry standards and regulations.
- Provided support during product recall efforts, ensuring proper documentation and timely communication with affected customers.
- Championed a culture of continuous improvement, encouraging team members to identify opportunities for process optimization and cost reduction.
- Managed cross-functional teams, driving continuous improvement efforts across multiple departments.
- Supported root cause and data analysis for defect reduction and process yield improvement.
- Led root cause analyses to identify and address problems in industrial production.
Senior Quality Systems Engineer
DePuy Synthes Joint Reconstruction
10.2015 - 05.2023
- Enhanced quality assurance processes, collaborating with cross-functional teams to identify and resolve system inefficiencies.
- Developed testing protocols for reducing product defects and ensuring compliance with industry standards.
- Improved product reliability by analyzing failure data and implementing corrective actions.
- Conducted root cause analysis to identify process improvement opportunities and prevent recurrence of issues.
- Implemented quality management systems to ensure consistency and high standards in production.
- Ensured compliance with regulatory requirements through regular audits and documentation reviews.
- Improved customer satisfaction by addressing quality concerns and implementing effective solutions.
- Developed training programs for staff to ensure adherence to quality standards.
- Collaborated with engineering teams to improve design and manufacturing processes for better efficiency.
- Facilitated implementation of corrective action plans to address non-conformance issues.
- Improved supplier quality management by developing robust evaluation and feedback systems.
- Led cross-departmental teams to drive quality improvements and achieve company objectives.
- Evaluated supplier performance, conducting audits and providing feedback to improve vendor relationships and ensure consistent material quality.
- Led training initiatives for staff on quality system processes, resulting in increased understanding and adherence to established procedures.
- Conducted root cause analysis to identify areas for improvement, leading to a reduction in product defects.
- Provided support during product recall efforts, ensuring proper documentation and timely communication with affected customers.
- Championed a culture of continuous improvement, encouraging team members to identify opportunities for process optimization and cost reduction.
- Managed cross-functional teams, driving continuous improvement efforts across multiple departments.
- Coordinated with regulatory agencies during audits, ensuring continued certification and compliance with relevant standards.
- Provided technical guidance to engineering teams, ensuring the successful integration of quality system requirements into product designs.
- Collaborated with other departments for timely resolution of customer complaints, enhancing overall customer experience.
- Supported root cause and data analysis for defect reduction and process yield improvement.
- Collaborated with cross-functional teams to develop and implement process changes.
- Led root cause analyses to identify and address problems in industrial production.
- Wrote safety procedures for industrial facilities, enforcing or exceeding industry standards.
Regulatory Compliance Specialist
Zimmer Biomet
02.2013 - 10.2015
- Championed process improvements within the company by identifying outdated practices and recommending innovative solutions that align with current regulatory requirements.
- Streamlined reporting processes for swift identification and resolution of potential regulatory violations.
- Established a culture of compliance within the organization by promoting transparency, communication, and ethical conduct among all team members.
- Collaborated with cross-functional teams to develop comprehensive risk management strategies and reduce exposure to non-compliance penalties.
- Enhanced transparency of compliance activities by developing easily accessible dashboards to track performance metrics and trends.
- Ensured regulatory compliance by conducting thorough audits and assessments of company policies and procedures.
- Advised senior leadership on potential risks associated with new products or services from a regulatory perspective before implementation or launch.
- Reduced non-compliance risks with proactive monitoring of changes in relevant legislation or industry standards affecting the organization''s operations.
- Stayed abreast of evolving regulations by attending seminars, conferences, webinars, and other professional development opportunities.
- Supported external audits by providing necessary documentation, addressing inquiries, and implementing corrective actions as needed.
- Facilitated open lines of communication between departments to foster an integrated approach to regulatory compliance management across all business units.
- Implemented robust record-keeping systems to ensure accurate tracking and easy retrieval of compliance-related information during inspections or audits.
- Conducted gap analyses to identify areas requiring improvement or enhancements within existing compliance frameworks.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Developed or tracked quality metrics.
- Provided pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Wrote or updated standard operating procedures, work instructions or policies.
Project Coordinator II
Medtronic
11.2003 - 02.2013
- Kept projects on schedule by managing deadlines and adjusting workflows.
- Supervised multiple projects from project start through delivery by prioritizing needs and delegating assignments.
- Enhanced team collaboration through regular meetings, fostering a positive work environment for increased productivity.
- Liaised between departments to facilitate communication and keep appropriate parties updated on project developments.
- Prepared meeting agendas and minutes for distribution and record keeping.
- Created job files for each project and maintained current data in each file.
- Coordinated cross-functional teams to achieve seamless collaboration in achieving project objectives.
- Maintained database and spreadsheets with accurate inventory and status.
- Maintained accurate documentation of all projects, facilitating efficient audits and future reference.
- Facilitated frequent progress reports and presentations to keep management informed about ongoing activities within their respective domains.
- Assisted with onboarding newly hired staff members and coached on task prioritization.
- Elevated overall quality of completed projects by consistently monitoring progress and addressing issues proactively.
- Ensured prompt resolution of any conflicts or obstacles encountered during the course of a project''s execution phase, helping maintain smooth workflow across departments involved in its completion process.
- Led project documentation efforts, ensuring accurate and timely updates were accessible, significantly reducing information gaps.
- Implemented digital project tracking system, simplifying progress monitoring and improving project delivery timeframes.
- Orchestrated onboarding of new team members, ensuring seamless integration into project workflows and culture.
- Fostered culture of continuous improvement by organizing regular review meetings, leading to identification and implementation of key process optimizations.
- Reported regularly to managers on project budget, progress, and technical problems.
- Monitored project progress, identified risks and took corrective action as needed.
- Tracked project and team member performance closely to quickly intervene in mistakes or delays.
- Recruited and oversaw personnel to achieve performance and quality targets.
Education
Bachelor of Science - Human Resources Management
Indiana Institute of Technology
Fort Wayne, IN05-2015
Skills
- Engineering change management
- Corrective and preventive actions
- Continuous improvement initiatives
- Cross-functional teamwork
- Failure modes and effects analysis
- Regulatory compliance
- Quality training and coaching
- Supplier quality management
- Process improvement techniques
- Expertise in quality management systems
- Quality documentation management
- Customer complaint handling
- Attention to detail
- Multitasking and organization
- Critical thinking
- Team collaboration
- Team leadership
- Quality assurance
- Root cause identification
- Risk management
- Process change documentation
- Failure investigation and analysis
- Root-cause analysis
- Protocol review
- Performance metrics
- SOP development
- Corrective action planning
- Process mapping
- Change management
- Technical writing
- Lean six sigma
- Non-conformance reports
- International regulatory compliance
- Internal audit coordination
- Non-conformance processes
- External audit support
- Process control documentation
- Quality improvement strategy
- Quality auditing
Accomplishments
- Supervised team of 22 staff members for SWE mentoring program.
- Enthusiastically served as SWE Global Leadership team site leader and liaison. Charged with delivering plant-wide employee training, development, and mentoring programs in a variety of key topics. Excellent interpersonal and coaching skills. By managing SWE created and lead the group using practices and objectives that will provide an employee-oriented, high performance culture that emphasizes empowerment, quality, productivity and standards, goal attainment, and the recruitment and ongoing development of a superior workforce. Along with this I have coordinated implementation of services, policies, and programs through Human Resources staff and Senior Management. I have carried out responsibilities in the following functional areas: departmental development, employee relations, training and development, organizational development.
Speaker and mentor
N.E.W Workshop (Non Traditional Employment for Women) INDIANA: Mentoring and providing a unique opportunity for students to hear from females employed in their respective career that can share their experience and answer some of their questions.
Mentoring over 200 young adults.
Certification
ISO 13585 Lead Auditor (TPECS) from BSI
ISO 13485 Lead Auditor Certification from Oriel STAT A MATRIX
Technical Writing from Rockhurst University
Implementing & Administering Windows SharePoint Services from Microsoft
Timeline
Senior Quality Engineer
Red Star Contract Manufacturing
10.2023 - Current
Senior Quality Systems Engineer
Avalign Technologies
05.2023 - 10.2023
Senior Quality Systems Engineer
DePuy Synthes Joint Reconstruction
10.2015 - 05.2023
Regulatory Compliance Specialist
Zimmer Biomet
02.2013 - 10.2015
Project Coordinator II
Medtronic
11.2003 - 02.2013
ISO 13585 Lead Auditor (TPECS) from BSI
ISO 13485 Lead Auditor Certification from Oriel STAT A MATRIX
Technical Writing from Rockhurst University
Implementing & Administering Windows SharePoint Services from Microsoft
Bachelor of Science - Human Resources Management
Indiana Institute of Technology
Similar Profiles
Scott HainesScott Haines
Production Team Leader at Red Star Contract ManufacturingProduction Team Leader at Red Star Contract Manufacturing
Angela BignellAngela Bignell
Laborer at Contract Manufacturing ServiceLaborer at Contract Manufacturing Service
Jacqi MorrisJacqi Morris
Finance & Planning Manager at Vision Contract ManufacturingFinance & Planning Manager at Vision Contract Manufacturing