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Quality Engineer
full-time•Jüri alevik
About this role
Overview
Make a global impact—join Repligen.We’re united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success—where every voice matters and every contribution drives progress. Join us!
The Quality Engineer is responsible for ensuring product and process quality throughout operations and New Product Introduction (NPI). This role works cross-functionally with suppliers, production, and design teams to resolve quality issues, support audits, and ensure compliance with internal procedures and customer requirements.
Responsibilities
- Communicate with suppliers to resolve quality issues, manage nonconformities, handle claims, and support supplier audits
- Support production quality problem-solving in cooperation with production and manufacturing engineers
- Interface with the design team to communicate and resolve quality issues arising during production
- Manage and support incoming inspection activities, including inspection criteria and issue resolution
- Plan, perform, and support internal audits to ensure compliance with quality systems and procedures
- Participate in the creation and review of User Requirement Specifications (URS), ensuring requirements are clearly defined and include appropriate quality criteria
- Perform gate checks in accordance with the NPI SOP to ensure deliverables meet quality requirements before progression to the next project phase
- Ensure document control and maintenance of Design History File (DHF) and Device Master Record (DMR)
- Participate in formal design reviews at each project stage to ensure quality deliverables are met
- Support FMEA activities in NPI projects to identify, reduce, and eliminate quality risks
- Review and sign off Verification & Validation documentation, Traceability Matrix, and Design Input files to confirm all URS requirements are fulfilled
Qualifications
- Bachelor’s degree in Engineering, Quality, or a related technical field
- Experience in quality engineering within manufacturing or regulated environments (e.g., medical devices, automotive, electronics)
- Knowledge of quality tools such as FMEA, root cause analysis, and corrective/preventive actions
- Familiarity with audits, document control, and quality management systems
- Strong communication skills and ability to collaborate across functions and with external suppliers
- Detail-oriented, analytical, and proactive problem solver
What Repligen Offers
Repligen offers you a competitive remuneration package, including a yearly bonus, additional health insurance package, sport benefits and flexible working hours. But most importantly Repligen offers you a stimulating, fast--paced environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team and a modern office in Jüri, Estonia
What you'll do
- The Quality Engineer ensures product and process quality throughout operations and New Product Introduction (NPI). This role involves cross-functional collaboration to resolve quality issues and support audits.
About Repligen
FRAUD ALERT: Please take note that it has come to our attention that individuals purporting to work for Repligen are reaching out to prospective job applicants using fraudulent email addresses. All legitimate communications from Repligen will be sent from an individual with an email address ending in @repligen.com. If you have any concerns that a communication may be fraudulent and you would like to confirm whether it is, you may email [email protected] and someone will respond.
Repligen is a bioprocessing-focused life sciences company bringing over 40 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs, principally monoclonal antibodies.
Repligen headquarters is in Waltham, Massachusetts and our manufacturing facilities are located around the world. We market our products globally through a direct commercial organization in the U.S., Europe and Asia, as well as through strategic partners in select markets.
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Frequently Asked Questions
What does a Quality Engineer do at Repligen?
As a Quality Engineer at Repligen, you will: the Quality Engineer ensures product and process quality throughout operations and New Product Introduction (NPI). This role involves cross-functional collaboration to resolve quality issues and support audits..
Is the Quality Engineer position at Repligen remote?
The Quality Engineer position at Repligen is based in Jüri alevik, Estonia. Contact the company through Clera for specific work arrangement details.
How do I apply for the Quality Engineer position at Repligen?
You can apply for the Quality Engineer position at Repligendirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.