Quality Engineer (Medical Device)
Accentuate Staffing is partnering with a fantastic Medical Device Manufacturer who is hiring for a Quality Systems Engineer. This is a contract to hire opportunity, offering competitive pay while working onsite. The ideal candidate has experience supporting the development and maintenance of quality systems for production, ensuring operational activities continuously comply with the QMS while adhering to all applicable regulatory requirements.
Responsibilities:
- Maintain the quality system to ensure that processes are continuously effective.
- Support and maintain key operational processes to enable rapid and effective correction of quality problems in a manner that prevents their recurrence, utilizing CAPA and NCMR.
- Engineering Change Requests and Notifications.
- Manage supplier CAPAs, NCMRs, records, evaluations and transfers.
- Support the DHR process by collecting, auditing, and filing documentation.
Requirements:
- Bachelors degree is required.
- 5+ years of Quality Systems experience.
- 2+ years of experience in a ISO 13485 regulated environment.
- Familiar with new product development, design control and other product life cycle activities.
- Extensive quality review experience to include: DHR review, product quality review, process deviation review, engineering change reviews for quality, nonconforming materials reviews for quality.
