Quality Engineer I - Repligen
Marlborough, MA
About the Job
The Quality Engineer I will report directly into the QA Manager.
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 the Systems and Hardware Service Depot including supporting calibration activities in accordance with ISO 17025 requirements. |
• Familiar with ISO 17025 calibration regulatory requirements. • Work with Service, Manufacturing, Product Management, R&D, and Planning in support of Service Depot related activities. Effective written and oral communication required with cross functional teams. • Must be familiar with Validation Principles and Concepts, Design Controls Processes in accordance with regulatory requirements (e.g., ISO 9001:2015, ISO 17025, CE, REACH, RoHS etc.). · Support creation and release of service spare parts, component BOMs, and review and release of change orders and change controls. • 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 service depot operations as necessary. · Investigate and provide quality support to customer complaints related to Marlborough Service Depot. · Responsible for reviewing, releasing, and generating certificates of quality for service spare parts. · Responsible for managing non-conformances, corrective actions, and deviations for the Marlborough Service Depot. |
• BA/BS degree (in a Biological Science, Engineering, or Physical Science required). • Experience with bioprocessing systems and hardware. • Must be familiar and have experience with ISO 9001:2015 and ISO 17025 calibration requirements. • Must have working knowledge of performing calibration activities and issuing calibration certificates. • Must have working knowledge of performing product review and release and creating and releasing certificates of quality. • 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 experience a plus. |