Joel Hernandez

Serves as a Quality Assurance Specialist with the responsibilities of managing CAPA/SCAR program, Change Management Program, and company-wide ISO 13485 compliance. Responsible for updating Quality Procedures and publishing to the company ISO System Index. Works with QA/Regulatory Manager during audit preparation and executing to ensure compliance and success for each facility. Generates monthly KPI reports through measuring compliance metrics, accompanied with presentation of analysis company-wide. Investigates all medical device related customer complains/cases and provides appropriate follow-up. Manages Complaints Log and Nonconforming Materials Log. Responsible for maintaining training records for all employees.

Key Responsibilities:

• Works with all levels of the organization to address nonconformities and determine corrective/preventive actions.
• Collaborates cross-functionally with plant management to ensure ISO 13485 compliance throughout WHIP MIX.
• Coordinates root cause analysis sessions with responsible departments upon initiation of Corrective Action Reports.
• Provides Guidance to all departments for regulatory documentation and technical writing of SOP's work instruction.
• Leads CAPA program via effective intercommunication, accountability of set due dates, and thorough documentation.

Key Achievements

• Optimized KPI report generation by increasing efficiency and reducing completion time to half of its antecedent.
• Conducted external and internal audits for the Colorado facility.
• Contributed to execute and the preparation of the new QMS software.
• Integrated a new QMS software and provided training for users.
• Enhanced the training completion to 100%.
• Instituted new method to analyze and track customer complaints.
• Created work instructions for processes and procedures that are in place.
• Developed detailed work instructions for rework of customer labels to comply with ISO 13485 requirements.
• Directed investigation team for root cause analysis on CAPA's from customer complaints, process or procedure, internal and external findings.

Served as a Quality Manager responsible for managing the QMS ensuring daily calibration and documentation is accurate and updated. Created quality procedures that align with ISO 9001 and 13485 requirements. Utilized the ERP system to determine traceability for production that were produced for customers. Communicating with customers for investigating complaints and on time delivery. Used CAPA program to identify the root cause of non-conformance, determine immediate resolutions, and implement preventive actions. Collaborate with vendors in requesting ISO certifications or documentation of COC/COA's.

Key Responsibilites:

• Worked with all levels of the organization to ensure the facility is complying with ISO requirements and to address any non-conformances.
• Collaborated cross-functionally with the CEO and managers to organize audit preparation, audit strategy, and execution.
• Coordinated with the CEO and mangers in management reviews for quality performance and objectives.
• Provided leadership as a subject matter expert for any issue related to the quality of the product.
• Maintained responsibility for managing the QMS and all quality documents.

Key Achievements:

• Directs investigation team upon finding a customer related nonconformance and executed corrective action plan.
• Improved quality training, production training, and management training in ordinance with ISO 9001, ISO 13485, and IATF 16949.
• Directed production, performance and quality objectives to keep team aligned with company goals.
• Delivered reports on quality control metrics to internal departments for analysis as well as to outside vendors and contractors for consideration in new contracts.
• Contributed to root cause evaluation to mitigate risk and foster continuous improvement.
• Created ISO documents within manufacturing facilities to comply with applicable regulations.
• Developed the QMS to refine production processes or update for conformity to new regulations or policies.

Served as a Director of Operations responsible for managing a team of 2 managers and 10 technicians ensuring daily calibration of production and quality performance. Daily collaboration with CEO and managers for production and quality metric. Conducted management review with mangers for quality metrics and quality objectives. Collaborated with customers on engineering changes and completion of PPAP's. Investigate non-conformances initiated from customer complaints and manufacturing issues.

• Oversaw all production and quality and collaborated with all department managers.
• Motivated and supported workers completing work to increase work quality, productivity, and efficiently.
• Improved quality training, production training, and management training in ordinance with ISO 9001.
• Conferred with other managers, technical personnel and team leaders to coordinate site work and maintain tight schedules.
• Contributed to root cause evaluation to mitigate risk and foster continuous improvement.
• Maintained ISO documents within manufacturing facilities to comply with applicable regulations.
• Reviewed QMS to refine production processes or update for conformity to new regulations or policies.
• Reviewed technical drawings for accuracy and thorough compliance.
• Transformed conceptualized ideas into designs, sketches, blueprints and technical diagrams with AutoCAD.
• Perform CAPA, nonconformities, and root cause analysis when an issues arise either with a customer or at the facility.

• Supervising and coordinating with the Quality Department team.
• Developed and maintained A&M Threader's Quality Management System with API, ISO 9001 and customers guidelines.
• Made sure each product met industry regulations and standards.
• Trained and led staff on proper QA standards.
• Performing investigations on nonconforming products to follow-up evaluations to determine efficacy of previously implemented corrective measures, recommending subsequent actions based on findings.
• Investigated performance to maintain employee adherence to quality and safety policies.
• Maintained policy, procedures, work instructions and projects for quality and continuous improvement agendas.
• Led staff education efforts on quality assurance (QA) and quality management policies, improving production outcomes.
• Recommended improvements to systems and procedures for increased productivity.

• Maintained the SQF and U.S.D.A. program/guidelines.
• Conducted the SQF, U.S.D.A. Food Defense,Internal Audits and Mock Recalls.
• Supervised and guided inspectors, technicians and other staff.
• Enforcing and maintaining GMP's, SOP's and SSOP's.
• Reviewed current standards and policies.
• Updating procedures and quality documentations.
• Continually Improving procedures and processes.
• Informed internal and external outcomes of quality activities to all personnel.
• Performed a root cause analysis.
• Maintained policy, procedures, work instructions and projects for quality and continuous improvement agendas.
• Collaborated with management to discuss effective plans for resolving major quality problems.

• Obtaining P&C, L&H certification thru the State of Colorado.
• Strategized long-term business objectives by assessing customer feedback for direction on process improvements.
• Drove insurance sales through development of new clientele.
• Engaged customers and provided high level of service by carefully explaining details about documents.
• Developed insurance cross-selling opportunities.
• Coordinated appointments and consultations with clients to identify individual needs

• Performed the HACCP verifications with the State of Colorado on various pasteurizers.
• Knowledge of different types of machinery.
• Set up machines for various jobs to maintain compliance with manufacturing thresholds and waste reduction initiatives.
• Compiled operational data into reports to help management spot trends and resolve problems.
• Calibrated each machine at beginning and end of each shift.
• Identified machinery issues and repaired parts to keep equipment up and running.
• Maintained correct temperature, levels and pressures on process systems and equipment.

• Supervising the production process setup and operation.
• Trained, mentored and inspired operators in safe operation of equipment.
• Set up and operated production equipment according to daily work orders and safety procedures.
• Checked machinery operation visually, addressed issues by performing minor maintenance.
• Inspected finished products for quality and adherence to customer specifications.
• Inspected quality of finished products, making minor repairs to meet project expectations.
• Oversaw the MSS, GMP's, SOP's, and SSOP's of the entire plant operations.
• Maintaining the SQF program and guidelines.
• Examined final products to check conformance with quality and design standards.