Supplier Quality Engineer – Auditor

Job not on LinkedIn

🔥 12 hours ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 16%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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MB&A

WebsiteLinkedInAll Job Openings

2 - 10 employees

Founded 2019

🏥 Healthcare

🎯 Recruiter

💼 Consulting

Healthcare • Recruitment • Consulting

MB&A is a boutique recruiting and consulting firm focused on the medical device manufacturing industry. They provide talent acquisition, staffing, and recruiting services as well as quality and regulatory consulting including quality system audits, audit and compliance services, management review preparation, remediation support, Quality Due Diligence, operations and engineering support, SaMD/SiMD quality systems management, start-up partnerships, and project management. MB&A leverages over 20 years of experience conducting quality system audits for medical device manufacturers and suppliers worldwide and partners with machine shops for manufacturing and sourcing support.

📋 Description

• Evaluate and select suppliers against documented criteria, including capability, past performance, and impact on device quality • Establish supplier monitoring and re-evaluation processes and take risk-based corrective action • Maintain complete, audit-ready supplier evaluation, selection, monitoring, and re-evaluation records • Clean up the approved supplier list where supporting evidence is insufficient • Define purchasing information, including product specifications, acceptance criteria, QMS requirements, and supplier personnel qualifications • Draft, negotiate, and maintain quality agreements requiring advance notification of supplier changes • Define verification levels for purchased products, from incoming inspection to source inspection, based on supplier risk • Assess the impact of supplier changes on products • Review supplier process validations for machining, coatings, cleaning, passivation, and sterilization • Confirm supplier support for implantable-device traceability records covering components and materials • Apply appropriate controls to outsourced processes for which the client remains responsible • Issue and manage SCARs, drive root-cause analysis, and verify effectiveness with suppliers • Track supplier performance through scorecards and trend data for data analysis and management review • Support supplier-related nonconformances, MRB decisions, and CAPAs • Plan and perform supplier qualification, surveillance, and for-cause audits • Write status updates for client leadership and flag risks early

🎯 Requirements

• 5+ years of quality engineering experience in medical devices • Supplier controls remediation experience, or experience supporting FDA inspection or notified body audit responses • Hands-on orthopedic experience with both implants and instruments; required • Direct supplier-facing work, including 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 • Ability to read engineering drawings, GD&T, material certificates, and FAI/FAIR packages • Strong written and verbal communication • Ability to work independently in a remote setting • Ability to travel up to 25% • Bachelor's degree in engineering or a related technical field, or equivalent experience • Preferred: experience with orthopedic secondary processes including coatings, cleaning, passivation, anodizing, laser marking, packaging, and sterilization • Preferred: experience owning or building a supplier quality program, or leading supplier quality teams • Preferred: familiarity with eQMS platforms for supplier management • Preferred certifications: ASQ CQA, CSQE, CQE, ISO 13485 Lead Auditor, MDSAP auditor training, PMP, or Six Sigma Green or Black Belt

🏖️ Benefits

• Contract employment • Remote work arrangement • Opportunity to take on audits, lead the supplier audit process, and step into project management as the program matures • Opportunity to work with emerging companies and large OEMs on audit readiness, remediation, manufacturing and design transfers, and supplier quality and oversight