As our ideal QA Manager, you are a critical thinker who will proactively improve the quality systems of the company through audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.
You develop, manage, coordinate, and evaluate the activities of the Quality Assurance function (Inspection) for Paramit Manufacturing. Ensuring the execution of the various inspections, manufacturing, and CAPA processes are in compliance with U.S. FDA 21 CFR 820 regulations, ISO 9001, ISO 13485:2016, the EU Medical Device Regulation (EU 2017/745), and other applicable regulatory agencies are the core of you and your team's work.
Essential Responsibilities and Job Duties:
- Ensures the Quality Management System is maintained in compliance with all applicable FDA Quality System Regulations, ISO 9001, ISO 13485:2016, the Medical Device Regulation
- Generates Quality inspection performance metrics
- Oversee and manage the Quality Assurance (Inspectors) organization. Ensure adequacy of resources, training compliance, and work output/quality.
- Oversees the in-process and final inspection functions.
- Supports and external audit programs and activities.
- Supports Management Reviews and preparation of Quality reports.
- Ensures the continued compliance of inspection activities to the Quality Management System Requirements for the Morgan Hill Manufacturing site.
- Ensures inspectors are certified to the appropriate standards (IPC 610, IPC 7711/21).
- Oversee the daily spot check program and manages the “Stop on Defect” program.
Minimum Experience and Education Requirements:
- Bachelor’s degree in Technology or Engineering or equivalent, or 5 to 15 years experience in the medical device industry; a minimum of ten years experience in Quality function; or equivalent combination of education and experience.
- Demonstrated experience in the use of Problem Solving Techniques.
- Regulatory knowledge specific to the FDA Quality System Regulations, ISO9001/ISO13485, and the Medical Device Directive (MDD) and Medical Device Regulation required.
- Proven ability to work in a cross-functional team environment.
- Excellent interpersonal and communication skills and a high level of computer literacy
- Preferred: Experience in the manufacture of PCBAs and box builds
- Previous supervisory/management of inspectors; this role has a large team of direct and second-level reports working across two shifts
- IPC 610 certification and training