Quality Control Specialist

Responsibilities

• Perform product receiving, in-process, and final inspections in accordance with written procedures, statistical sampling plans, engineering drawings, and product specifications, documenting nonconforming products as appropriate.
• May administer the equipment calibration and maintenance system, environmental monitoring program, and bioburden monitoring program, including coordination with subcontracted service providers.
• Coincide or lead nonconforming product reviews, including Material Review Board activities and NCR/NCMR disposition, to support timely product decisions.
• Maintain quality system logs, records, and filing systems, and ensure accurate traceability of components and finished products.
• Maintain and operate inspection and test equipment, and provide input on inspection methods and quality procedures.
• Support corrective and preventive action activities, supplier evaluations, and supplier performance monitoring.
• Review product lot history records and support lot release to finished goods inventory, as applicable.
• Support finished goods shipping and commercial release activities, as applicable.
• Contribute to improvements in quality system procedures and work instructions related to areas of responsibility.
• Train and advise other employees on quality-related requirements and ensure effective communication across functions.
• Represent areas of responsibility during internal and external quality audits and support audit readiness.

Qualifications

• High school diploma or equivalent required.
• Minimum of two years of experience with hands on quality inspection in a medical device manufacturing environment required.
• Startup or small-company experience preferred.
• Catheter manufacturing experience preferred.
• Proficiency with word processing and spreadsheet software required.
• Full professional proficiency in English required.

Preferred Qualifications

• Experience reading and interpreting engineering drawings, specifications, and statistical sampling plans.
• Experience using dimensional and visual inspection equipment, including microscopes.
• Strong hand-eye coordination, manual dexterity, color vision, and visual acuity, corrected if necessary.
• Ability to work under pressure, manage multiple deadlines, and maintain effective working relationships.
• Strong attention to detail, organizational skills, and oral and written communication skills.