Overview
The Quality Engineer I will report directly into the Principal Quality Engineer. This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for providing Process/Quality Engineering support for new product development and improvements and supporting manufacturing for commercial products.
Responsibilities
- Must be familiar with Validation Principles and Concepts, Design Controls Processes in accordance with regulatory requirements (e.g., Quality ISO standards, ASME BPE, CE, BPOG, REACH, etc.).
- Supports the New Product Introduction (NPI) team with deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. Work with multi-functional product development teams to help identify new required suppliers.
- Experience in areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. Product line support will focus on plastic and stainless-steel devices and associated consumables used for cell culture, filtration and chromatography products.
- Supports the comprehensive completion of risk management (FMEA), Design and Process Verification activities for products and processes.
- Assists in the development and validation of appropriate test methods for product and process performance.
- Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results.
- Review of Equipment IOPQ’s in support of commercial operations.
Qualifications
- BA/BS degree (in a Biological Science, Engineering, or Physical Science required).
- Experience with stainless steel and plastic device, systems/software and consumable products and associated manufacturing processes.
- Basic understanding of cell culture and filtration and chromatography operations in a bioprocess setting is required for this position.
- 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.
What Repligen Offers
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, collaborative 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.
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