Quality Assurance Inspector

Gentuity; Sudbury (MA); On-site; USD 55,000 - 75,000; Full time

Job summary

Gentuity in Sudbury, MA is seeking a Quality Inspector to perform inspection of incoming materials, components, and subassemblies, and complete first article inspections on request.

You will conduct in-process and finished product inspection (sterile and non-sterile), review DHRs, release conforming products, and initiate NCRs for non-conforming items, while maintaining GMP/GDP compliance.

Qualifications

• High school diploma or GED with quality control training in medical devices preferred.
• Able to read and interpret engineering drawings and specifications.
• Experience using measurement tools and sampling plans; GMP/GDP knowledge helpful.
• Familiar with ISO 13485, CFR 21-820, and related quality systems.

Responsibilities

• Inspect incoming materials, components, and subassemblies for conformance.
• Complete First Article Inspections upon request and perform in-process checks.
• Inspect finished products (sterile and non-sterile) and conduct testing as needed.
• Review DHRs for subassemblies and finished goods and initiate NCR records.
• Conduct product release activities for conforming products.
• Quarantine non-conforming items and participate in investigations.
• Maintain calibration/PM of inspection equipment and promote GMP/GDP compliance.
• Assist in internal/external audit preparations and coordinate with teams.

Skills

Detail oriented

Reading drawings

Effective communicator

Team collaboration

Education

High School Diploma or GED

Tools

Calipers

Micrometers

Pin gauges

Tensile testers

Job description

Description

• Perform Inspection of incoming materials, components, and subassemblies
• Complete First Article Inspections upon request.
• Perform In-process and finished (sterile and non-sterile, disposable, and durable) product inspection and testing.
• Perform DHR reviews for subassemblies and finished goods.
• Conduct Product Release activities for all conforming products.
• Initiate NCR records for all non-conforming products, components, and subassemblies.
• Quarantine non-conforming product and participate in the investigation process.
• Maintain Inspection area equipment calibration and PM
• Adhere and promote GMP and GDP principles.
• Assist in external/internal audit preparations.

Requirements

EXPERIENCE/SKILL REQUIREMENTS:

• Organizational skills and attention to detail.
• Firsthand experience using measuring tools such as but no limited to calipers, micrometers, pin gauges and tensile testers.
• Ability to read and understand drawings.
• Experience working with sampling plan.
• Understanding of ISO 13485, CFR21-820, ISO 146444-1, 2 and 3.
• Able to take direction, ownership, and responsibility for QMS related activities.
• Positive and cooperative communication and collaboration with all levels to employees, contractors and vendors.
• Strong understanding of quality control standards and testing techniques.
• Electronic Quality System experience.
• Proficient with Microsoft Office, Excel, and other electronic systems.
• Medical device experience is a plus.
• Experience working a cleanroom is a plus.

EDUCATIONAL REQUIREMENTS:

• High School Diploma, GED, or equivalent with additional training in quality control in medical device industry or similar field.