Quality Control

A key med device client of ours is looking to hire a Quality Control specialist. This would be 2nd shift (12pm-9pm) onsite M-F.

Perform quality assurance and quality control inspection duties, including inspection of implants, instruments and gauges as required to ensure the dimensional and visual integrity of product in accordance with all required quality specifications, standards, goals and objectives. Perform receiving inspection and related activities.

High School diploma or equivalent. Prefer vocational/technical school training. Prefer formal GD&T training (Geometric Dimensioning and Tolerancing).

• Must have 3+ years of product inspection experience in a cGMP manufacturing environment.
• Prefer experience with inspection of hand finishing, buffing, laser-marking, masking or blasting processes for implants, instruments or other production parts.
• Demonstrated ability to read blueprints.
• Demonstrated proficiency in the use of all standard inspection tools including calipers, micrometers, height gages and comparators.
• Demonstrated understanding of Inspection Sampling Plans.
• Demonstrated familiarity with GD&T.
• Demonstrated computer skills including basic proficiency in MS Outlook and intermediate proficiency in MS Word and Excel.
• Must be able to lift up to 25 pounds on an occasional basis.
• Must be willing and able to work weekday, weekend and mandatory overtime hours as required to meet the production demands of the team.
• Demonstrated ability to train others.
• Demonstrated communication and interpersonal skills and the ability to work in a team-based environment that heavily emphasized quality, performance, cross‑training, customer service and accountability.
• Demonstrated understanding of FDA CFR 820 and EN 13485 Regulations.
• Demonstrated experience in performing incoming receiving inspection.
• Prefer demonstrated understanding of packaging or clean line process and assembly for implants, instruments, or production parts.

• Perform dimensional and visual inspection to blueprint using standard gages, custom gages and comparators.
• Read and inspect to blueprints and/or inspection guide sheets.
• Perform Document Review and Product Verification Inspection (PVI) in compliance to GMP requirements.
• Perform material and component Receiving Inspections, Inspect, calibrate and qualify gages;
  Verify First Article Inspection (FAI) data.
• Perform Oracle system transactions related to Router Inspections;
  Segregate, quarantine and complete documentation for non-conforming materials when necessary.