Quality Engineer II
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.
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
• Designs and Develops forms and instructions for recording,
evaluating, and reporting quality data
• Interfaces with suppliers to improve or resolve quality
• Perform Gauge R&R Studies, IQ, OQ, and PQ Concepts, CAPA
• Perform Metrology and General Statistics to aid the
improvement of processes.
• Will perform supplier audits as necessary
• Will assist in LHR reviews
• BS degree in Science Engineering or related discipline.
• Minimum of 3 years of experience in a regulated medical
• ASQ certified Quality Engineer recommended
• Experience and understanding of polyurethane thermoplastic
• Six Sigma Green/Black belt recommended.
• Excellent verbal and written communication skills
• Medical Device Experience preferred
Creganna provides the medical device industry with innovative delivery device solutions.
We focus on the area of minimally invasive...