Supplier Quality Engineer
TAE Life Sciences is an exciting startup company that has developed a 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 implementing and maintaining a supplier quality program.
• Perform audit of suppliers key processes and Quality System in accordance with an audit schedule and Quality Agreements
• Support processes for supplier approval and maintenance of the Approved Suppliers List
• Review and approve purchased part specifications
• Lead MRB to resolve quality issues of manufactured parts
• Lead improvements to processes related to supplier quality including internal inspections, supplier testing, MRB, SCAR, NCR, supplier audits, etc.
• Maintain supplier files in an audit-ready status
• Work internally & with suppliers to identify quality risks, mitigations & control plans
• Provide management with status updates on assigned responsibilities and escalate issues in a timely fashion
To succeed in this role, you should have the following qualifications / skills.
Qualifications / Skills:
• Minimum B.S. Engineering degree (Mechanical Engineering, or Biomedical Engineering, or Manufacturing Engineering degrees preferred) with 4+ years industry experience (medical devices or automotive)
• Experience conducting supplier audits
• Working knowledge of risk analysis and process qualification
• Working knowledge of standards and regulations such as FDA QSR, ISO13485, ISO14971
• 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% domestic and some international