This is a remote position.
About MB&A
MB&A is a medical device quality, regulatory, and operations firm founded by Monica Burt. Our senior team brings 25 years inside MedTech and more than 200 FDA and ISO audits. We're practitioners first, consultants second.
We partner with manufacturers, from emerging companies to large OEMs, on audit readiness, 483 and Warning Letter remediation, manufacturing and design transfers, and supplier quality and oversight. We don't hand over a report and walk away. We sit in the room and close the gaps.
The Role
We're looking for a hands-on supplier quality engineer with real orthopedic experience. You'll work inside a client's quality organization to strengthen how they select, qualify, monitor, and control their suppliers under QMSR (21 CFR Part 820), which incorporates ISO 13485:2016 by reference.
Most of the early work is supplier quality engineering. Think supplier files, risk classification, quality agreements, SCARs, and purchased product controls. Supplier auditing is also in scope. As the program matures, there's room for this role to take on audits, lead the supplier audit process, and step into project management.
What You'll Do
The work maps directly to the supplier controls in ISO 13485:2016 Chapter 7 (Product Realization), mainly clause 7.4 Purchasing, along with the clauses that connect to it.
- Evaluate and select suppliers against documented criteria: their ability to meet requirements, past performance, and effect on device quality, with controls proportionate to risk (ISO 13485 7.4.1).
- Set up supplier monitoring and re-evaluation. Take action when a supplier doesn't meet purchasing requirements, scaled to the risk involved (7.4.1).
- Keep supplier evaluation, selection, monitoring, and re-evaluation records complete and audit-ready. Clean up the approved supplier list where the evidence doesn't hold up (7.4.1).
- Define purchasing information: product specifications, acceptance criteria, QMS requirements, and supplier personnel qualification where needed (7.4.2).
- Draft, negotiate, and maintain quality agreements that require suppliers to notify the client of changes before they're implemented (7.4.2).
- Set the right level of verification for purchased product, from incoming inspection to source inspection, based on supplier evaluation and risk. Assess the impact of supplier changes on product (7.4.3).
- Review supplier process validations for special processes like machining, coatings, cleaning, passivation, and sterilization (7.5.6 and 7.5.7).
- Confirm suppliers support the traceability records required for implantable devices, including components and materials (7.5.9.2).
- Apply the same controls to outsourced processes the client remains responsible for (4.1.5).
- Issue and manage SCARs. Drive root cause and verify effectiveness with suppliers (8.5.2).
- Track supplier performance with scorecards and trend data that feed data analysis and management review (8.4).
- Support supplier-related nonconformances, MRB decisions, and CAPAs.
- Plan and perform supplier audits, including qualification, surveillance, and for-cause audits, as the engagement grows.
- Write clear status updates for client leadership and flag risks early.
Requirements
Need to Have
- 5+ years of quality engineering experience in medical devices.
- Supplier controls remediation experience, or supporting FDA inspection or notified body audit responses.
- Hands-on orthopedic experience with both implants and instruments; this is required.
- Direct supplier-facing work: qualification, SCARs, supplier changes, and incoming quality.
- Working knowledge of QMSR and ISO 13485:2016, especially Chapter 7 purchasing and production controls, plus ISO 14971 risk management.
- Comfort reading engineering drawings, GD&T, material certs, and FAI/FAIR packages.
- Strong written and verbal communication. You'll be talking to client leadership, peers, and suppliers, often in the same week.
- The ability to work independently in a remote setting and travel up to 25%.
- Bachelor's degree in engineering or a related technical field, or equivalent experience.
Nice to Have
- Experience with critical orthopedic secondary processes: coatings (HA, plasma spray), cleaning, passivation, anodizing, laser marking, packaging, and sterilization (EO, gamma).
- Experience owning or building a supplier quality program, or leading supplier quality teams.
- Familiarity with eQMS platforms for supplier management.
- Certifications such as ASQ CQA, CSQE, or CQE; ISO 13485 Lead Auditor; MDSAP auditor training; PMP; or Six Sigma Green or Black Belt.
— Sarah J.
·
Marketing Manager
★★★★★
Verified
