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Quality Engineer I
Location:
Marlborough, MA
Description:
Overview 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. Responsibilities * 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. Qualifications * 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. PDN-9bef9d4e-37cf-48de-8376-2f7b636d2593
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More About this Listing: Quality Engineer I
Quality Engineer I is a Quality Assurance Quality Engineer Job at Repligen located in Marlborough MA. Find other listings like Quality Engineer I by searching Oodle for Quality Assurance Quality Engineer Jobs.
Quality Engineer I is a Quality Assurance Quality Engineer Job at Repligen located in Marlborough MA. Find other listings like Quality Engineer I by searching Oodle for Quality Assurance Quality Engineer Jobs.