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| Sr. Quality Engineer - Job # 1919 |
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Client Synopsis:
Full Scale Solutions is currently recruiting for the following position. Our Client is a rapidly growing, privately held medical device company based in Raleigh-Durham NC.
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Essential Duties and Responsibilities:
We are currently seeking a Senior Quality Engineer who will be responsible for providing quality leadership and support in implementing, managing and controlling our Client's quality system to meet and maintain compliance with ISO 13485, MDD and CFR 820.
Responsibilities include but are not limited to:
- Support company continuous improvement programs, and implement new quality systems and techniques as required to meet company needs.
- Write and review procedures related to product quality and the quality system.
- Train and support personnel in using the Quality Management System procedures.
- Participate in setting up and maintaining procedure and records files.
- Assist with the management of the Complaint Handling program, including presenting trend data; ensuring complaint investigations are performed, including adequate root cause analysis; and providing recommendations for corrective & preventive actions.
- Support the Corrective and Preventive Action (CAPA) process and review information for changes and to ensure timely closure.
- Perform internal and supplier audits and assist with supplier selection.
- Provide guidance and assist with product development including: design control compliance, risk management, and verification and validation of medical devices.
- Provide support to the Engineering, Purchasing, and Manufacturing departments during the design transfer including IQ/OQ/PQ, material specifications, and quality control procedures.
- Develop and complete inspection protocols for receipt of incoming parts and/or final product.
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Required Qualifications & Expertise:
- BS technical degree.
- 5 to 8 years experience in the Class I/II medical device industry, with hands on experience in ISO, MDD, and FDA quality systems.
- Individual must have hands on experience with medical devices dealing.
- Compliance with FDA, MDD, and ISO 13485 quality system experience.
- Experience with risk management, verification and validation of medical devices.
- Implementation of inspection processes.
- Corrective/Preventative Action and Complaint systems.
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 Our Client offers a competitive salary and exceptional benefit package.
For confidential consideration please submit a resume and salary requirements to
claire@fullscalesolutions.com.
Full Scale Solutions is an equal opportunity employer.
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