Quality Engineer I

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.