Quality Control Inspector II

Repligen Corporation•Waltham, MA

7d•Onsite

About The Position

As a Quality Control Inspector II, you will inspect, audit, and evaluate incoming materials and manufacturing processes using a variety of visual inspection techniques and precision measuring equipment. You will work cross-functionally with Operations, Engineering, Supply Chain, and Quality teams to ensure materials and components meet both customer expectations and internal quality standards. Success in this role requires a strong commitment to quality and compliance, attention to detail, a collaborative mindset, and the confidence to identify and communicate quality concerns that support continuous improvement and operational excellence. “This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.”

Requirements

High School diploma, two-year technical degree, or equivalent education from an accredited technical institution required.
Relevant machine shop, inspection, quality, or related industry experience will also be considered.
Minimum of 2 years of experience in Quality Assurance within an ISO 13485, ISO 9001, or similar regulated Quality Management System environment.
Demonstrated proficiency with Microsoft Office applications, including Outlook, Excel, and Word.
Strong ability to communicate and collaborate effectively across departments and functional teams.
Ability to information proactively and provide timely updates on quality issues and inspection activities.
Experience contributing to project teams and cross-functional initiatives.
Exceptional attention to detail and commitment to producing accurate, high-quality work.
Demonstrated ability to take ownership of responsibilities, exercise sound judgment, and maintain high ethical standards when making quality-related decisions.

Nice To Haves

Bachelor's degree in a science-related discipline or equivalent industry experience preferred.
Experience with inspection practices and standards within medical device, bioprocessing equipment, aerospace, military, or other highly regulated manufacturing industries preferred.
working knowledge of Geometric Dimensioning and Tolerancing (GD&T) techniques.
Understanding of Good Documentation Practices (GDP) preferred.

Responsibilities

Conduct inspections of incoming supplier materials and approve or reject materials according to documented quality processes and specifications.
Verify and part number labels to approved materials in accordance with inventory part labeling specifications.
Utilize inspection tools and equipment, including calipers, Micro-Hite systems, comparators, and other precision measuring instruments.
Interpret engineering drawings, specifications, purchase orders, statements of work, and industry standards to determine quality acceptance criteria and product conformity.
Perform inspections of machined parts based on drawing requirements using precision measurement tools.
Follow applicable Safety Data Sheets (SDS) and safety procedures related to handling materials and chemicals.
Support a culture of continuous improvement and operational excellence by identifying opportunities to enhance quality processes and systems.
Perform inspections using established sampling plans and inspection methodologies.
Communicate non-conforming material findings clearly and promptly to management and relevant stakeholders, demonstrating integrity and accountability in quality decision-making.
Accurately document inspection activities, results, and associated records using Microsoft Office tools and quality documentation systems.
Partner with internal teams to identify, communicate, and support quality improvement opportunities that enhance both internal operations and customer satisfaction.
Support First Article Inspection (FAI) activities.
Support investigations and documentation related to corrective actions, deviations, and customer complaints.
Maintain a clean, organized, and safe work environment.
Comply with company safety requirements, policies, and quality standards.
Perform other duties as assigned.