QUALITY ENGINEER II
Creganna 4 reviews - Campbell, CA
Full-time, Temporary

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Quality Engineer II

Creganna-Tactx Medical is a fast growing medical device company looking for a Quality Engineer who is highly versatile. The right candidate will be able to adapt quickly to changing priorities and manage multiple projects simultaneously. We offer Paid Time Off, a Comprehensive Medical package, 401k matching, Life Insurance and Tuition Reimbursement.

Summary:

The Quality Engineer (QE) is responsible for establishing, implementing and maintaining systems and /or services to measure and improve product quality, cost, and customer service while ensuring full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements.

Essential Duties and Responsibilities: • Participates as a key member of new product development, to help ensure that the new product quality plans, validation plans, specifications, are properly established.
• Assists in the Material Review Board to ensure products are accurately dispositioned within a timely manner, while ensuring appropriate corrective and preventative actions are initiated and regulatory requirements are met.
• Designs and Develops forms and instructions for recording, evaluating, and reporting quality data
• Interfaces with suppliers to improve or resolve quality issues
• Perform Gauge R&R Studies, IQ, OQ, and PQ Concepts, CAPA compliance.
• Perform Metrology and General Statistics to aid the improvement of processes.
• Will perform supplier audits as necessary
• Will assist in LHR reviews
Requirements:

• BS degree in Science Engineering or related discipline.

• Minimum of 3 years of experience in a regulated medical device environment.

• ASQ certified Quality Engineer recommended

• Experience and understanding of polyurethane thermoplastic material

• Six Sigma Green/Black belt recommended.

• Excellent verbal and written communication skills

• Medical Device Experience preferred

About this company
4 reviews
Creganna provides the medical device industry with innovative delivery device solutions. We focus on the area of minimally invasive...