Supplier Quality Engineer - Medical

AMARIS GROUP SA; Bothell (WA); On-site; USD 110,000 - 140,000; Full time

Job summary

Amaris Consulting is seeking a skilled Supplier Quality Engineer to join its SQE team for a medical-device emergency care portfolio. You will manage supplier quality issues from rejection through corrective action, qualification, and effectiveness checks, in a regulated ISO 13485/FDA environment.

You will participate in MRB, lead defect investigations, manage NCRs/SCARs, and drive APQP/PPAP part qualification with suppliers. On-site Bothell, WA, with US work authorization required.

Qualifications

• 5+ years in Supplier Quality Engineering in medical devices or FDA-regulated sector.
• Knowledge of ISO 13485 and FDA 21 CFR 820.

Responsibilities

• Review supplier-related rejections and drive disposition.
• Lead MRB investigations and defect analyses.
• Process SAP QM defects, NCRs, and dispositions.
• Coordinate supplier quality notifications and CAPAs.
• Support IQ/OQ/PQ and APQP/PPAP activities.
• Engage with suppliers for corrective actions and quality improvements.
• Act as supplier-quality point of contact during FDA audits.

Skills

SAP QM

MRB involvement

8D problem solving

APQP/PPAP

ISO 13485 knowledge

FDA 21 CFR 820

Education

Bachelor's degree in engineering

Tools

SAP QM

Job description

Location: 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.

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.)

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.

Who are we?

Amaris Consulting isan independent technologyconsulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of7,600 people spread across 5 continents and more than 60countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.