Quality Control Inspector I — ISO 9001 Medical Devices

Repligen; Hopkinton (MA); On-site; USD 33,000 - 41,000; Full time

Benefits offered by this job

Health/dental/vision

Paid time off

Retirement benefits

Flexible spending accounts

Job summary

Repligen in Hopkinton, MA is seeking a QC Inspector I to actively participate in the ISO 9001 Quality Management System and inspect in-process and final assemblies of single-use parts at our Hopkinton facility. You will use visual inspection and measuring tools to ensure conformance with internal and customer quality standards.

The role emphasizes integrity, compliance, and collaboration as part of our leadership behaviors.

Qualifications

• High school diploma or two-year technical degree preferred.
• Experience in ISO 9001 quality systems or equivalent.
• Familiar with medical devices/bioprocessing equipment inspection practices.
• Ability to communicate across departments and document results timely.

Responsibilities

• Inspect single-use assembly designs and approve/reject per process.
• Apply part number labels to production materials per labeling spec.
• Use inspection tools (calipers, Micro-Hite, rulers) to verify conformance.
• Communicate non-conforming material to management (verbal or written).
• Support root cause investigations for non-conformances.
• Maintain organized work area and document results accurately.
• Identify continuous improvement opportunities for the quality program.
• Comply with safety regulations and internal policies.

Skills

Attention to detail

Communication skills

Microsoft Office

Team collaboration

Auditing

Education

High School diploma

Two-year technical degree

Tools

Calipers

Micro-Hite

Rulers

Outlook

Excel

Word

Job description

Repligen in Hopkinton, MA is seeking a QC Inspector I to actively participate in the ISO 9001 Quality Management System and inspect in-process and final assemblies of single-use parts at our Hopkinton facility. You will use visual inspection and measuring tools to ensure conformance with internal and customer quality standards.

The role emphasizes integrity, compliance, and collaboration as part of our leadership behaviors.