Supplier Quality Engineer – Auditor

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess and choose suppliers based on established criteria, which include their capabilities, historical performance, and influence on product quality.

• Develop processes for supplier monitoring and re-evaluation, implementing corrective actions based on risk assessments.

• Maintain thorough, audit-ready records for supplier evaluation, selection, monitoring, and re-evaluation.

• Refine the approved supplier list when there is inadequate supporting evidence.

• Specify purchasing information, including product specifications, acceptance criteria, quality management system requirements, and qualifications of supplier personnel.

• Create, negotiate, and uphold quality agreements that necessitate prior notification of any supplier changes.

• Establish verification levels for purchased products, ranging from incoming inspections to source inspections, based on supplier risk.

• Evaluate the effects of supplier changes on products.

• Review supplier process validations in areas such as machining, coatings, cleaning, passivation, and sterilization.

• Ensure supplier support for traceability records of implantable devices covering components and materials.

• Implement appropriate controls for outsourced processes for which the client retains accountability.

• Issue and oversee Supplier Corrective Action Requests (SCARs), conduct root-cause analyses, and ensure effectiveness with suppliers.

• Monitor supplier performance using scorecards and trend data for data analysis and management evaluations.

• Assist in addressing supplier-related nonconformities, Material Review Board (MRB) decisions, and Corrective and Preventive Actions (CAPAs).

• Plan and execute supplier qualification, surveillance, and for-cause audits.

• Provide status updates to client leadership and promptly identify potential risks.

⛳️ Requirements

• A minimum of 5 years of experience in quality engineering within the medical device sector.

• Experience in supplier control remediation or in supporting responses to FDA inspections or notified body audits.

• Required hands-on experience in orthopedics, including both implants and instruments.

• Experience in direct supplier interactions, encompassing qualification, SCARs, supplier modifications, and incoming quality assessments.

• Proficient knowledge of QMSR and ISO 13485:2016, particularly Chapter 7 regarding purchasing and production controls, along with ISO 14971 risk management.

• Capability to interpret engineering drawings, GD&T, material certificates, and FAI/FAIR documentation.

• Excellent written and verbal communication skills.

• Capacity to work independently in a remote environment.

• Willingness to travel up to 25%.

• A bachelor’s degree in engineering or a related technical discipline, or equivalent experience.

• Preferred: experience with orthopedic secondary processes such as coatings, cleaning, passivation, anodizing, laser marking, packaging, and sterilization.

• Preferred: experience in managing or developing a supplier quality program, or leading supplier quality teams.

• Preferred: familiarity with electronic Quality Management Systems (eQMS) for supplier management.

• Preferred certifications include ASQ CQA, CSQE, CQE, ISO 13485 Lead Auditor, MDSAP auditor training, PMP, or Six Sigma Green or Black Belt.

🏝️ Benefits

• Contract employment opportunity.

• Flexible remote work arrangement.

• Chance to engage in audits, lead the supplier audit process, and move into project management as the program evolves.

• Opportunity to collaborate with emerging companies and large OEMs on audit readiness, remediation, manufacturing and design transfers, and supplier quality oversight.