Job descriptionLocation: Bothell, WA, on-site
Travel: Occasional domestic travel
About the role Amaris Consulting is looking for a Supplier Quality Engineer to join an established SQE team supporting a medical-device emergency care portfolio.
You'll manage supplier-related quality issues from initial rejection through investigation, corrective action, qualification, and effectiveness checks. The role covers daily Material Review Board activity, supplier development, quality notifications, and part qualification in a regulated environment governed by ISO 13485 and FDA 21 CFR 820.
Your work will directly support the quality and safety of life-critical medical devices.
What you'll do - Review supplier-related rejections from the warehouse and production line, then drive appropriate disposition.
- Attend the daily Material Review Board and lead defect investigations.
- Process defect data and manage the Quality Notification workflow in SAP QM.
- Keep quality dispositions on schedule and properly documented.
- Issue and manage Supplier Quality Notifications and Supplier Corrective Action Requests.
- Track supplier acknowledgement, corrective-action deadlines, containment, root-cause analysis, and effectiveness checks.
- Lead component and process qualification activities using APQP and PPAP.
- Support supplier-process validation through IQ, OQ, and PQ.
- Partner with suppliers on corrective actions and quality improvement plans.
- Act as a supplier-quality point of contact during FDA inspections and customer or quality-system audits.
What you'll bring Required experience - 5+ years of Supplier Quality Engineering experience in the medical-device industry or another FDA-regulated sector, such as pharmaceutical, aerospace, or automotive.
- Working knowledge of ISO 13485 and FDA 21 CFR 820.
- Hands-on experience with SAP QM, including quality notifications, defect processing, and disposition.
- Experience participating in MRB meetings and leading defect investigations.
- Experience managing SQNs, SCARs, and 8D corrective-action activities.
- Experience with APQP and PPAP part qualification.
- Experience supporting IQ, OQ, and PQ process validation.
- Supplier-quality experience across plastic injection molding, PCBA, and PCB components.
- Confidence working with FDA investigators and responding to audit questions.
- Ability to work on-site in Bothell, WA.
- US work authorization.
Preferred qualifications - ASQ CQE, CSQP, or an equivalent certification.
- Working knowledge of 8D, 5-Why, Ishikawa analysis, basic SPC, GD&T, and engineering drawings.
- Previous experience with Philips or another large medical-device OEM.
- Experience managing counterfeit-part risks and electronic-component obsolescence.
Why join this role? You'll work closely with suppliers, manufacturing teams, engineering, and regulatory stakeholders on products where quality decisions matter every day. The role combines shop-floor investigation, supplier engagement, and regulated quality work across a broad medical-device portfolio.
Why choose us - An international community bringing together more than 110 different nationalities
- An environment where trust is central: 70% of our leaders started their careers at the entry level
- A strong training system with our internal Academy and more than 250 modules available
- A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)
