Supplier Quality Engineer – Medical Devices / Surgical Robotics

We are seeking an experienced Supplier Quality Engineer to oversee contract manufacturers and suppliers supporting advanced robotic surgical technologies. This role will lead supplier quality activities throughout the product lifecycle, including supplier changes, qualification, validation, quality system development, and continuous improvement.

The ideal candidate has strong experience working with medical device suppliers and contract manufacturers and is knowledgeable in
ISO 13485, 21 CFR Part 820, PPAP, validation, FMEA, and supplier change control.





Key Responsibilities


- Lead, support, review, and approve Supplier Change Requests (SCRs) and related change-control activities.
- Manage supplier and contract manufacturer activities involving process validation, Test Method Validation (TMV), PPAP, SCAPA/CAPA, and QMS compliance.
- Develop, implement, and maintain supplier quality systems and documentation, including:
- Quality Plans
- Control Plans
- Process and Design FMEAs
- Measurement System Analyses
- Process qualification and validation documentation
- Qualify new suppliers and contract manufacturers according to established quality and regulatory requirements.
- Ensure suppliers consistently deliver compliant, high-quality finished goods, components, materials, and services.
- Review and approve supplier manufacturing processes, quality controls, and product qualifications.
- Evaluate supplier change requests for potential product, process, regulatory, and quality-system impact.
- Monitor supplier performance and lead the investigation and resolution of supplier-related quality issues.
- Support supplier corrective and preventive actions, root-cause investigations, and continuous improvement initiatives.
- Conduct or support supplier audits to verify compliance with GMP, internal quality standards, and applicable regulatory requirements.
- Partner with Engineering, Manufacturing, Regulatory, Operations, and other cross-functional stakeholders.
- Recommend improvements to supplier processes, quality systems, service, delivery, and cost performance.
- Provide technical quality guidance to suppliers and internal project teams.






Required Qualifications


- Bachelor’s degree in Engineering, Science, Electronics, or another related technical discipline.
- Minimum of 4 years of relevant supplier quality, manufacturing quality, or quality engineering experience; or an advanced degree with at least
2 years of relevant experience.
- Experience supporting suppliers or contract manufacturers in a regulated manufacturing environment.
- Practical experience with:
- Supplier Change Requests and change control
- Process and equipment validation
- Test Method Validation
- PPAP
- SCAPA, CAPA, or SCAR
- Quality Management Systems
- Quality Plans and Control Plans
- FMEA or PFMEA
- Knowledge of medical device regulations and standards, including ISO 13485 and 21 CFR Part 820.
- Ability to independently manage moderately complex supplier quality projects and assignments.
- Strong problem-solving, documentation, communication, and cross-functional collaboration skills.






Preferred Qualifications


- Supplier quality experience within the medical device, surgical robotics, healthcare technology, or similarly regulated industry.
- Experience managing finished-goods contract manufacturers.
- Familiarity with GMP requirements, supplier auditing, process qualification, risk management, and measurement system analysis.
- Experience mentoring junior quality professionals or providing technical guidance to project teams.