Supplier Qual Engineer II
Job Title: Supplier Quality Engineer Location: 195 McDermott Rd North Haven Connecticut 06473 Duration: 12 Months Job ID: 26510 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)