Site Quality Manager – Medical Device

Mauricio is Looking for a Site Quality Manager. The Site Quality Manager will manage daily activities for Quality Assurance, Quality Ops Engineering, Calibration and R&I, which will include performing QA and QC review of manufacturing records and inspections, checks, and tests of incoming materials, components used in the manufacture of medical devices and finished goods. The Site Quality Manager will also ensure products meet specified requirements and work performed complies with cGMP/GDP policies and internal procedures, will be responsible for periodic environmental monitoring of clean room areas, ensure adequate resources are available to meet manufacturing demand and meet cost and timeliness quality metrics of the QA/QC/R&I departments, and will be responsible for reporting area metrics and continuous improvement of procedures and practices.

Responsibilities:

• Supervise daily Receiving Inspection and Assembly Inspection tasks.

• Assign priorities and resources.

• Provide support to manufacturing to ensure daily workloads and deadlines are achieved.

• Hire and train QA/QC employees. Implement and enforce company policies and departmental procedures.

• Evaluate and review individual performance annually or as needed.

• Ensure a safe working environment and enforce safety rules and policies.

• Evaluate issues and make recommendations for corrective action to department manager.

• Work with Production and Quality Assurance Management to provide feedback to assemblers regarding accuracy of assembly procedures.

• Support resolution of issues at the supplier impacting product quality.

• Collaborate with the supplier quality to in the supplier qualification, approval and selection process.

• Participate in construction and/or revision of inspection procedures and protocols.

• Assist in conducting and documenting process and system audits using specific regulations and company procedures as audit standards.

• Assist in maintenance of Quality Systems including Internal Audits, CAPA, Complaints, and Non-conforming Material Reports.

• Coordinate calibration of all applicable equipment, tools, and fixtures.

• Support environmental monitoring of clean room areas.

• Lead receiving inspection test method validation activities.

• Ensure a safe working environment and enforce safety rules and policies.

• Evaluate issues and make recommendations for corrective action and improvement to department manager.

• Supervise and monitor attendance for QA/QC teams and maintain timekeeping activities.

• Identifies hazards and mitigates risks related to Client’s products, processes, and Quality System.

• Reports risks to executive management.

• Take site quality leadership responsibilities and establish partnership and collaboration with the stakeholder functions.

Qualifications:

Education:

• Bachelor’s degree in Engineering from a four-year college or university; or related major preferred.

Experience:

• Ten years of relevant experience in a biomedical industry with a Bachelor’s degree.
• 3-4 years of people management experience, including but not limited to hiring, performance management and coaching.

Featured benefits

• 401(k)
• Dental insurance
• Medical insurance
• Vision insurance