Senior Quality Engineer

The Senior Quality Engineer works with internal teams, suppliers and customers to analyze data, develop solutions and make recommendations and decisions to support and improve manufacturing processes.

• Leads and manages multiple customer projects aimed at process improvement and addressing customer needs.
• Collaborates with customers on process change approvals.
• Leads and manages quality system processes through routine meetings, data analysis and timely completion of project work.
• Supports the maintenance and control of the quality management system specifically quality system documents (internal and external), quality system records, device history records, and final product release.
• Works with Customers, Sales, and Engineering on validation & quality planning activities for new or existing programs. Performs validation activities as part of supplier qualifications and changes.
• Reviews drawings and recommends inspection and gauging methodology on new or existing programs.
• Participates in customer, supplier and regulatory audits.
• Works as part as Supplier Quality Team to assess and evaluate existing suppliers for quality and performance, and to qualify new suppliers through evaluations, audits, and surveys

• Five or more years hands‑on quality engineering experience in comparable role in med device, aerospace, or automotive manufacturing
• Experience leading and executing CAPAs, preferably in contract manufacturing or machining industry
• Bachelor’s degree in an Engineering discipline required (biomedical, chemical, materials, or mechanical preferred).
• Must have experience managing multiple customer and/or supplier projects
• Outstanding analytical, project management and communication skills required
• Must have outstanding organizational and time management skills with demonstrated ability to meet deadlines in fast‑paced environment
• Understanding of SPC, FMEA, DOE, inspection methods and equipment required
• Experience preparing, coordinating and executing validation activities including: IQ, OQ, PQ, and MSV
• Experience with maintaining and monitoring controlled environments (cleanroom) a plus
• Strong working knowledge of ISO 9001, ISO 13485, and FDA QMSR
• ASQ CQT, CQA and/or CQE certification is a plus

Our employees enjoy an entrepreneurial work experience where everyone’s contributions are important and visible. Manufacturing facilities are state‑of‑the‑art, clean, lab‑like and provide the tools and resources needed to be successful. Continuous growth is developed through collaborative project work, high‑tech problem‑solving and interaction with customers and key internal stakeholders. We offer an outstanding comp/benefits package that we welcome the opportunity to discuss.

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