Quality Assurance Supervisor

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Responsibilities

·        Supervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in order to meet product quality standards.

·        Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.

·        Oversee the “On Hold” product program, including the status, release, and destruction of “Rejected” products.

·        Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.

·        Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support in order to meet product quality standards.

·        Ensure good performance by quality assurance technicians/auditors by mentoring, training, setting expectations, providing accountability, and performing evaluations.

·        Investigate product, and process deviations, identify root cause, and develop corrective and preventative actions.

·        Provide leadership and direction to QA Techs by managing the workload, training and employee relations issues.

Qualifications

• Minimum of five years' quality experience in an ISO13485 and FDA regulated production environment, including supervision.
• Be well versed in 13485 and 21 CFR 820 Quality Management Systems Requirements. Experience with ISO14001 Quality Management Systems Requirements a plus.

·        Demonstrated expertise in building Quality Plans including strategy and tactics that have successfully met Quality KPI’s and Quality Goals.

·        Experience with Lean, FMEA, MRB, NCMR, CAPA, Root Cause Analysis, IQ/OQ/PQ Validations, Supplier Management, Internal Auditing, Key Characteristics, and establishing Quality Metrics.

·        Excellent written and verbal communication skills across a broad variety of departments.

·        Ability to positively and comfortably handle and prioritize multiple tasks in a fast-paced environment with self-motivation and focused attention to detail.

• Ability to develop protocols, training materials and reports with the guidance of resources.
• Self starter; take charge, positive and proactive attitude.