Duties and Responsibilities:
- Manages the Supplier Quality Program
- Performs external surveys and audits on new and current suppliers and documents results of such visits.
- Maintains the Approved Supplier List.
- Compiles and issues Supplier Report Cards on Class “A” suppliers.
- Calculates and publishes Supplier Quality Ratings.
- Administers all Supplier Corrective Action Requests and verifies that supplier initiated corrective action was effective prior to SCAR closure.
- Supplier validation review. Review supplier generated validation documentation (for process and product).
- Manages the Material Review Board and all associated activity.
- Leads the Corrective Action/Preventive Action program for nonconformity related to Operations or suppliers.
- Participate in product Risk Analysis sessions and review verification/validation documentation upon request.
- Develops inspection and testing methods and participates in the preparation of quality assurance plans, specifications and procedures.
- Active participation in the review of engineering specifications, protocols, and reports to assure that adequate quality assurance requirements are met, and designs are adequately transferred into manufacturing with high process capability measured against Critical to Quality Design Output Requirements.
- Takes a leadership role in assuring all activities in the area of manufacturing equipment, processes and software validations meet FDA and International regulatory requirements.
- Analyze field returns, production data and other information to understand and correct design, manufacturing and user-related problems.
- BS Degree with Five to Seven years of experience in medical device industry, with preference given to experience with products with electronic and software components.
- Experienced with the application and implementation of GMP/QSR/ISO 13485/MDD/MDR and Canadian Medical Device regulations a plus.
- Experience in addressing Corrective Actions in a regulated industry. Ability to investigate, understand, review and document complex design issues. Excellent problem-solving skills (root cause analysis).
- ASQ certification with active local membership is preferred.
- Demonstrated knowledge/experience of Quality Management System requirements in FDA regulated environments and understanding of ISO 13485 and applicable Medical Device Directives.