Quality Engineer II
Location: North Haven, CT 06473 (Onsite)
Contract Duration: 12 + months with possible extension
Industry: Medical Devices – Robotic Surgical Technologies
Job Summary
We are seeking an experienced Quality Engineer II – Supplier Quality to support Robotic Surgical Technologies, focusing on finished goods manufactured by contract manufacturers (CMs). The successful candidate will be responsible for supplier quality management, quality management system (QMS) compliance, supplier change control, process validation, and continuous improvement initiatives.
This role involves collaborating with new and existing contract manufacturers and suppliers to establish, implement, and maintain robust quality assurance systems that meet medical device industry standards and regulatory requirements.
Key Responsibilities
- Lead, support, review, and approve Supplier Change Requests (SCRs), validations, Test Method Validations (TMV), Production Part Approval Process (PPAP), Supplier Corrective and Preventive Actions (SCAPA), and Quality Management System (QMS) activities.
- Manage supplier selection, supplier change requests, part and process qualification, and manufacturing quality requirements.
- Develop, implement, and maintain supplier quality documentation, including Quality Plans, Control Plans, Failure Mode and Effects Analyses (FMEAs), and Measurement System Analyses (MSAs).
- Collaborate with contract manufacturers and suppliers to ensure compliance with established quality standards and regulatory requirements.
- Support the development and maintenance of QMS processes related to supplier manufacturing operations.
- Identify opportunities to improve product quality, manufacturing processes, technical performance, service, and cost efficiency.
- Review supplier documentation and qualification records to ensure product and process requirements are met.
- Partner with cross-functional teams and external suppliers to resolve quality issues and support ongoing compliance.
Required Qualifications
- Bachelor’s degree in Engineering, a scientific discipline, electronics, or another relevant technical field.
- Minimum of 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.
- Experience in supplier quality engineering, supplier change control, process validation, and quality management systems.
- Knowledge of medical device industry requirements, including ISO 13485 and 21 CFR Part 820.
- Familiarity with PPAP, MSA, FMEA, Control Plans, Quality Plans, and supplier corrective action processes.
- Experience working with contract manufacturers and suppliers in a regulated manufacturing environment.
Preferred Skills
- Strong analytical and problem-solving skills.
- Ability to review and approve technical quality documentation.
- Effective communication and collaboration skills when working with suppliers and cross-functional teams.
- Experience driving supplier quality improvements and maintaining compliance in medical device manufacturing.
