Experienced Quality Engineer (Medical Device) – RTP/Top $$
Our client, an RTP area medical device company that is one of the fastest growing in the country, is actively recruiting for a very sharp and industrious Quality Engineer to join its outstanding team.
This company is developing cutting edge surgical tools that have been widely embraced by the medical community. It is essential that impeccable procedures are in place to ensure consistent quality of product. This Quality Engineer will instrumental in those efforts.
Key things to note:
- These are mechanical tools with an electronic/software component. Similar exposure is strongly preferred.
- The company has marketed products (FDA approved) as well as numerous products in development. Although the focus will be commercial, this Engineer may also be involved in contributing a Quality perspective to new product design.
- The company offers a corporate culture that is empowered, dynamic and appreciative, and the Quality team embodies its “people matter” philosophy. Seek technically-skilled Quality Engineer, with a positive energy and a collaborative work style.
- The company operates under cGMP and ISO 13485 standards, and related exposure is required.
- This company is in high growth mode. Right candidate will bring a Best Practices “building” approach to the role.
Company will pay excellent wage to attract and retain a star.
- Follows the design control process as per written procedures and documentation
- Performs risk management activities including creation and maintenance of risk management files
- Assures verification and validation testing meets statistical principles and is adequately documented and performed
- Participates in change control process by assisting with impact analysis to suppliers, manufacturing process, tools and fixtures, and inspection
- Leads Quality aspects of the Supplier Management process, e.g., lead supplier audits / supplier corrective actions
- Acts as liaison between manufacturing (internal and supplier) and Research and Development
- Leads CAPA and Non-Conformance investigations
- Participates in the continuous improvement of the Quality Engineering system
- Applies Quality Engineering principles to product development from concept to market launch
This company is growing, and Quality systems are being developed and enhanced to meet the needs of the future. Seek industrious and knowledgeable Quality professional who can contribute broadly.
Ideal candidate will offer a related degree and 3+ years of broad-based Quality experience in a medical device setting. Software design and validation exposure would be a valuable plus. Other priorities include:
- Understanding of design control, disciplined product development processes, Regulatory/Quality requirements
- Working knowledge of common Quality tools (i.e. Cpk/Ppk, DOE, Quality Reporting, etc.).
- Equipment and process validations experience
- Knowledge of relevant standards including ISO13485, 21 CFR Part 820 and ISO 14971
- ISO 13485 and FDA inspections experience a plus
- Sterile manufacturing and packaging as well as engineering enhancement tools (e.g. Six Sigma) preferred
- ASQ Certification desirable (CQE, CBA, CQM, CRE, etc.)
Finally and critically, we seek a hands-on, make-things-happen worker; someone who brings ingenuity and initiative; someone who sees a need and fills it; one who works exceedingly well in mission-driven, team-oriented setting. This is a very exciting time at a very exciting company. We seek a contributor who will thrive.
This is an immediate need. Please forward Word resume for prompt consideration. Local candidates only.