The Quality Engineer I will report directly into the QA Manager or Director, QA/QC.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for providing Quality Engineering support for the Repligen Hopkinton, MA facility, specifically Fluid Management Assembly Product Line, including the manufacturing of 2D and 3D film bags which are included in single use assembly products manufactured at the site.

This position must be proficient in quality engineering principles in support of sustaining engineering, new product development, continuous improvement and management of product/process change control. This position will own and champion key quality engineering functions throughout the organization, have industry regulatory knowledge and be sought out by others for product knowledge.

·  Working collaboratively with various departments to provide quality engineering support to produce a Quality product.

·  Supports New Product Introduction (NPI) team with deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes.

·  Play a key role in the transfer of manufacturing processes to the Repligen Hopkinton site and subsequent engineering tasks as part of overall continuous improvement initiatives.

• Works independently and champions continuous improvement of risk management (FMEA) as well as Design and Process Verification activities for products and processes.

• Assists in the development and validation of appropriate test methods for product and process performance within manufacturing and QC initiatives.

• Assist in the evaluation of manufacturing defects (recalls, non-conforming material, customer complaints). Ensure thorough investigation of quality issues identifying root causes and implementing corrective actions.

• Working knowledge of Lean and Six Sigma methodologies as appropriate to achieve optimal results.

·  Review and authoring of Equipment IOPQ’s in support of commercial operations.

• BA/BS degree (in a Biological Science, Engineering, or Physical Science required).

• Proven experience with plastic devices and consumable products along with the associated manufacturing processes in supporting quality engineering initiatives.

·  Must have an understanding with Validation Principles and Concepts, Design Controls Processes in accordance with regulatory requirements for purposes of new manufacturing operations.

·  Must have understanding/working knowledge in the support of industry regulatory requirements

·  Experience in areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes.

• Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred.

• Minimum of 2+ years’ experience as a Quality Engineer in an ISO 9001 Quality Management System or equivalent

• Internal Auditing

Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance 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 in Waltham, MA.