Contract Supplier Quality Engineer - Medical Device

Tri Alpha Energy   •  

Foothill Ranch, CA

Industry: Energy & Utilities


5 - 7 years

Posted 25 days ago


TAE Life Sciences has developed breakthrough technology for the clinical investigation of Boron Neutron Capture Therapy (BNCT) to provide a treatment option for patients with malignancies that are difficult to treat through traditional methods, such as head, neck and brain cancers.

Our proprietary accelerator-based BNCT platform combines two well-known modalities - biological targeting and radiation therapy - for precision treatment at the cellular level. TAE Life Sciences now stands ready to bring this promising, previously inaccessible, treatment to hospital settings.

We are currently looking for an experienced Supplier Quality Engineer to join our team. In this role, you shall be responsible for developing, implementing and maintaining a supplier quality program.

Essential Functions:

  •  Perform audits (Product-Specific & Quality System) & follow up on closure of any non-conformances
  •  Support supplier approval process and maintenance of the Approved Suppliers List
  •  Implement Quality Agreements
  • Develop and maintain auditschedules
  •  Improve processes for first article, factory acceptance tests and documentation, incoming product acceptance, MRB, SCAR, NCR, supplier deviations, supplier change control, supplier audits, and traceability of parts received
  •  Chair MRB and follow up on closure of investigations and corrective actions of quality issues
  •  Review and approve part specifications
  •  Maintain supplier files in an audit-ready status
  •  Work internally & with suppliers to identify CTQs, supplier process quality risks, & process control plans
  •  Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
    Lead supplier process improvements 

To succeed in this role, you should have the following skills and experience


  • BS in Mechanical  Engineering degree and minimum of 6 years industry experience in Supplier Quality or manufacturing of electro-mechanical systems/products/solutions for the medical, or automotive industries
  • A working knowledge of manufacturing processes for commodities such as printed circuit board assemblies, power supplies, mechanical parts (plastics, machined parts, sheet metal), cables, etc.
  • Experience with supplier quality management: quality concepts/tools/methods (e. g. FMEA, IQ/OQ/PQ, MSA, etc.), quality issue resolution and quality monitoring measures.
  • Direct work experience with related standards and regulations such as FDA QSR, ISO13485, ISO14971 and relevant guidance documents
  • Prior experiencesupporting the development of Capital Equipment is preferred
  • Understanding of Procurement, hands-on experience managing suppliers is required
  • Must be able to work effectively with a diverse group of people, including senior management, project managers and software practitioners
  • Good verbal (including presentation) and written communication skills
  • Excellent analytical skills
  • High level of initiative with ability to self-manage
  • Strong interpersonal skills with ability to work both independently and as part of a team
  • Ability to travel up to 30%.