Quality Engineer
4 weeks ago
- 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.
Requirements:
- 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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