Quality Control Inspector II

Overview: The QC Inspector I report directly to the QC Inspector Lead, QA Manager or Director. This position is responsible to actively participate in the Repligen ISO 13485 Quality Management System. This role is responsible for inspecting, auditing, and reporting on incoming materials and processes using various visual techniques and measuring equipment to ensure conformance to the organization and customer quality standards. Responsibilities: Mechanical inspection of incoming product from suppliers according to documented processes. Includes physical inspection and paperwork inspection to verify conformance to requirements. Requires demonstrated use of mechanical inspection hand tools and CMM, FARO a plus. Mechanical inspection is performed on machined parts based on drawing requirements using precision measuring tools Electronics inspection will include verification of components to engineering records, documentation requirements. Identify and document results of inspections. Clearly communicating nonconformances to specified requirements Able to access and interpret engineering drawings, specifications, purchase orders, statement of work and standards to determine quality status. Good organization skills and Microsoft Office software to accurately document and maintain associated paperwork and inspection results in a consistent and timely fashion Provide QA floor support activities including participating in cost out activities, additional data collecting and maintaining Quality data storage Identify and communicate continuous improvement opportunities for the quality program for customers internal and external. Perform final inspection of completed product as needed Qualifications: High School diploma or Two-year technical degree (ASME) or equivalent from an accredited technical institution is preferred. Machine shop experience in the quality discipline or a related field will be considered. Strong mechanical background, minimum 3-years of experience Familiar with medical devices, bioprocessing equipment, military or aerospace industry Experience with ISO 9001, ISO 13485, AS9100 or equivalent QMS standards Requires demonstrated use of mechanical inspection hand tools and CMM, FARO preferred Requires demonstrated use of basic Microsoft Office tools (Outlook, Excel, Word) Ability to read/interpret blueprints and diagrams Working knowledge of GD&T Familiarity with ASME, BPE codes. Team oriented with good written and verbal skills What Repligen Offers: Excellent Benefits! Health Insurance available on day one 4 Competitive Medical Plan Options Dental, Vision, Life and Disability Insurance Plans 401K Health Care Savings Account Well Being Programs 20 Days of PTO Tuition Reimbursement Program

Created: 2024-10-19