Supplier Quality Engineer - Medical

Amaris Consulting | Part of Mantu; Bothell (WA); Vor Ort; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Amaris Consulting is seeking 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, in an environment governed by ISO 13485 and FDA 21 CFR 820.

This on-site role in Bothell, WA requires MRB participation, SAP QM expertise, and collaboration with suppliers, manufacturing, and regulatory

Qualifikationen

• 5+ years of Supplier Quality Engineering experience in FDA-regulated sectors.
• Working knowledge of ISO 13485 and FDA 21 CFR 820.
• Hands-on SAP QM experience with notifications, defect processing, and disposition.
• Experience leading MRB meetings and defect investigations.
• Experience managing SQNs, SCARs and 8D activities.
• Experience with APQP and PPAP part qualification.
• Experience supporting IQ, OQ and PQ process validation.
• Experience with plastic injection molding, PCBA, PCB components.

Aufgaben

• Review supplier-related rejections and drive disposition.
• Attend MRB meetings and lead defect investigations.
• Process defect data and manage QN workflow in SAP QM.
• Keep dispositions on schedule and documented.
• Issue and manage Supplier Quality Notifications and SCARs.
• Track corrective actions, containment, and effectiveness.
• Lead component/process qualification activities using APQP/PPAP.
• Support supplier process validation (IQ/OQ/PQ).
• Collaborate with suppliers on corrective actions and quality improvements.
• Serve as supplier-quality point during FDA inspections and audits.

Kenntnisse

Supplier Quality Engineering

MRB experience

Regulatory knowledge

Quality systems thinking

Tools

SAP QM

APQP/PPAP

IQ/OQ/PQ

QNs/Dispositions

Jobbeschreibung

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.

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.)

Amaris Consulting promotes equal opportunities.

We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment.

In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.