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Quality Engineer

Katalyst Healthcares & Life Sciences
Westford, MA
Closing date
Jun 11, 2024

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The purpose of this position is to initiate medical device quality assurance activities.

These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards.

This position will also support device complaint investigation and failure analysis as required.

Essential Duties and Responsibilities: Develop incoming inspection processes and document incoming inspection activities.

Provide in-process QA support to include inspection and document review.

Complete final acceptance activities.

Manage the sterilization process, including validations and product sterile loads.

Track nonconforming material and lead Material Review Board (MRB) efforts.

Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.

Lead complaint investigations on returned product.

Manage corrective action and quality improvement activities.

Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.

Assist in the performance of quality system internal auditing.

Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.


Bachelor's degree required, strongly prefer in Engineering

Minimum of 2 years of experience in manufacturing space working with suppliers/vendors.

Must be able to understand manufacturing so not looking for supplier "auditors . Must be "Technical who understand line manufacturing.

Process validation exp. With IQ, OQ and PQ a must

Must have a medical device background

Must be able to speak and work with suppliers/vendors.

Will be responsible for corrective action with suppliers/vendors

Process change management

Must have problem solving skills thru CAPA investigations.

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