Overview
We are seeking an experienced Quality Engineer II that will actively participate in the Repligen ISO 9001:2015 Quality Management System. This role is responsible for providing Quality Engineering support for new product development, manufacturing transfer activities 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 verify new product development deliverables and compile product Design History Files to support product release.
- 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 hardware devices and associated consumables used for biotech 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.
- Review of Equipment IOPQ’s in support of commercial operations.
- Strong organization skills with the ability to effectively muti-talk and prioritize
- Self-motivated with sound judgment and problem-solving skills.
- Assists with customer complaint investigations when required
- Effective in executing change controls and running change control review board meetings.
- Review and approval of nonconformances, deviations, failure investigations and corrective action plans prior to implementation when required.
- Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results
Qualifications
• BA/BS degree (in a Biological Science, Engineering, or Physical Science required).
• Must have prior experience in New Product Development Quality Engineering.
• Experience with biotech hardware 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 3-5 years’ experience as a Quality Engineer in an ISO 9001 Quality Management System or equivalent.
• Internal Auditing.
