Supplier Qual Engineer II

Job Title:
Supplier Quality Engineer

Location:

195 McDermott Rd North Haven Connecticut 06473
Duration: 12 Months
Job

Pay Range: $45-50/hr

Seeking a Supplier Quality Engineer with experience in supplier quality management, supplier change requests (SCR), and medical device quality systems to support Contract Manufacturers (CMs) for Robotic Surgical Technologies.

Key responsibilities include:
Managing supplier quality activities and SCR processing
Reviewing and approving Validation, TMV, PPAP, SCAPA, and QMS documentation
Supporting supplier qualification, audits, and process improvements
Developing and maintaining Quality Plans, Control Plans, FMEAs, and technical quality systems
Working with suppliers and contract manufacturers to ensure compliance with quality and regulatory standards
Monitoring supplier performance and resolving quality issues

Must Have Skills:

Experience with SCR, Validation, PPAP, SCAPA, QMS, and supplier quality processes
Knowledge of Quality Plans, Control Plans, FMEA, MSA
Familiarity with ISO 13485, FDA 21 CFR 820, and GMP requirements
Medical device industry experience
Strong supplier quality and problem-solving skills

Qualifications:
Bachelor’s degree in Engineering, Scientific, Electronics, or related technical field
4+ years of relevant experience (or advanced degree with 2+ years)