This position will be responsible for leading supplier quality engineering activities associated within the business. Reporting up to executive leadership, this individual will serve as the lead Supplier Quality Engineer to monitor supplier performance and drive improvements.
Our latest client is a privately-held OEM, Class III medical device manufacturer based in the Andover MA area. This company has three major devices which are commercialized in Europe, Canada, and Australia and has recently been FDA-approved for commercialization in the United States.
- Monitor supplier performance and drive improvement and resolution of non-conformances directly with supplier through corrective action process.
- Increase number of source inspections and Dock-to-stock items.
- Establish and report on supplier Key Performance Indicators (KPIs).
- Manage the Approved Supplier List (ASL) and supplier audit schedule.
- Lead Supplier audit activities.
- Partner with R&D engineering to identify and qualify new suppliers.
- Bachelor's Degree (B.S.) in mechanical engineering, mechanical engineering technology, biomedical engineering (or other technical degree applicable to position being filled) or related discipline from an accredited university
- Minimum of five (5) years of Quality Engineering or Supplier Quality Engineering experience in the medical device industry
- Working knowledge 21 CFR Part 820, ISO 13485, ISO 9001
- Thorough understanding of CAPA/SCAR and closed loop corrective action system
- Lead auditor experience (Internal and/or Supplier auditing) is required
- Strong base salary
- Growing company - FDA approved and anticipates FDA approval for several additional devices within next few years
- Lead role - this individual will serve as the Lead Supplier Quality Engineer for all Supplier Quality activity
- Life-saving, Class III Medical Device
- Leads and mentors junior engineers with opportunity for growth to build out Supplier Quality team
- Competitive benefits package
- Market leader with top ratings