Experienced Quality Engineer (Medical Devices) – Direct Hire/Top $$
Our client, an RTP area medical device company that produces innovative and industry-changing surgical equipment, is expanding exponentially and actively recruiting for a highly capable Quality Engineer to join its outstanding team.
The company has received regulatory approval in multiple countries and is experiencing explosive growth. It is essential that impeccable procedures are in place to ensure consistent quality of product. This Quality Engineer will be instrumental in that effort.
Things to note:
- This is a broad-based Quality role including Design Control, Validation, Complaint Investigations, Audits, etc.. Familiarity with all would be important.
- These are mechanical tools with an electronic component. Similar exposure would be valuable.
- Company has marketed products as well as a rich pipeline. Although the focus will be commercial, this QE may also contribute to new product design
- Company operates under cGMP and ISO 13485 standards. Related exposure is expected.
- This is a highly collaborative role in an empowered and appreciative setting. Right candidate will complement top-notch skills with a positive and congenial work style
This Quality Engineer will focus primarily on supporting the product support teams from design transfer, manufacturing, and post-market activities. S/he will be involved in design control process, risk management activities, verification/validation testing, change control, supplier audits, CAPA/non-conformance investigations, etc. We seek an industrious and knowledgeable candidate who enjoys being the hub.
- Contributes to design and process verification and validation activities including definition and qualification of test methods, acceptance criteria and statistical principles. Assists in writing and reviewing protocols, reports, work instructions, and SOPs to support product and process development
- Supports risk management activities including creation and maintenance of risk management files
- Manages complaints globally, cooperating with EU team in complaints opening, complaints investigations, complaints metrics and complaints risk assessments
- Supports Design Control activities including assisting in the development of design concepts, prototypes and product specifications as part of the development team
- Acts as an internal auditor
- Participates in the continuous improvement of the quality engineering system
- Ensures compliance with Company quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles
Ideal candidate will offer a related degree and 3+ years of Quality Engineering experience in a similar medical device setting. Software exposure preferred.
Other priorities include:
- Substantial experience with Design Control – as well as all other functions highlighted above
- Solid understanding of approaches to work breakdown, prioritization, resource allocation, and problem solving
- ISO 13485 inspections and FDA inspections experience a plus
- Proficiency in use of Excel for metrics
- ASQ Certification a plus
- History of growth and longevity in previous roles
Finally, we seek a hands-on, make-things-happen worker who brings ingenuity and initiative. This is an exciting time. Seek a contributor who will thrive.
Please forward Word resume for prompt consideration. Local candidates only at this time.