Supplier Quality Engineer / Auditor

Zohorecruit; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

MB&A is a medical device quality, regulatory, and operations firm seeking a hands-on supplier quality engineer with real orthopedic experience. You will strengthen supplier qualification, monitoring, and controls within QMSR (21 CFR 820) and ISO 13485:2016 by reference.

The role evolves to include supplier audits and project leadership as the engagement grows. Responsibilities cover supplier selection, risk-based verification, quality agreements, SCARs, and trend analysis.

Qualifications

• Minimum 5 years of quality engineering in medical devices.
• Hands-on orthopedic implants and instruments experience.
• Supplier-facing duties: qualification, SCARs, supplier changes, incoming quality.
• Knowledge of QMSR & ISO 13485:2016, Chapter 7 purchasing/production controls.
• Ability to read engineering drawings, GD&T, material certs, FAI/FAIR packages.
• Strong written and verbal communication with leadership and suppliers.
• Willingness to travel up to 25% and work remotely.

Responsibilities

• Evaluate and select suppliers using documented criteria and risk-based controls.
• Monitor and re-evaluate suppliers; take action when requirements are not met.
• Maintain audit-ready supplier evaluation records and cleanup of approved list.
• Define purchasing information including specs, acceptance criteria, and QMS requirements.
• Draft and maintain quality agreements; ensure supplier-change notifications prior to implementation.
• Set appropriate verification level for purchased product based on risk.
• Review supplier process validations for machining, coatings, cleaning, passivation, sterilization.
• Ensure traceability records for implantable components and materials.
• Apply controls to outsourced processes and manage SCARs, root-cause, and CAPAs.
• Track supplier performance with scorecards and trend data for management reviews.
• Plan and perform supplier audits; participate in qualification, surveillance, and for-cause audits.
• Provide clear status updates to client leadership and flag risks early.

Skills

Quality engineering

Written communication

Verbal communication

Autonomy

Travel readiness

Reading drawings

Education

Bachelor's degree in engineering

Tools

QMSR & ISO 13485:2016

GD&T

F AI/FAIR packages

eQMS platforms

Job description

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.