Job: Quality Assurance (Medical Equipment) – Contract/Consultant (Flex Schedule), Frankel Staffing Partners, RTP, NC
Our client, a RTP area medical device company developing cutting edge surgical tools/equipment, has an immediate need for a highly skilled and knowledgeable Quality professional to join its team.
This is a contract role expected to last 6 months or longer. Client is flexible on schedule, and will consider those seeking 30 hours or more.
Position will involve managing all QA functions including those related to contract manufacturers and overseas facilities. Ability to manage and enhance the functioning quality management system including maintaining active ISO 13485 certifications will be important. Further, this contractor will be critically involved in FDA submissions. Related expertise will be essential.
Client will pay excellent wage to retain the seasoned professional who can significantly contribute to all Quality functions. Class III device expertise will be important.
Specific duties will include:
- Quality Systems
o Implement and improve policies and procedures for compliance to requirements, such as ISO13485, EU’s Medical Device Directive and FDA’s Quality System Regulations (21 CFR 820).
o Assure that all personnel are trained and compliant to company procedures. Maintain document control, change control, and records management.
o Lead CAPA board, post-market surveillance activities through company feedback mechanisms, and communicate to management for proper resourcing to ensure the highest level of quality products.
- Quality Engineering
o Manage Quality Engineering functions including risk management file implementation during design and management through the post-market phase.
o Ensure QEs employ proper validation strategies for the design as well as the process development of new products.
o Guide investigation of feedback (complaints, non-conformances, etc.) through use of structured problem solving methodologies.
- Quality Control and Manufacturing Support
o Perform final release of products from suppliers, contract manufacturers, and in-house manufactured components.
o Maintain validated state of production including ensuring re-validation efforts are performed when required
o Work collaboratively with manufacturing engineering to reduce cost, variability, and labor in the production of products
Ideal candidate will offer a related degree and 7+ years of broad-based Quality experience in a medical device setting, including Class III expertise. Other priorities include:
o FDA submissions
o Design and Manufacturing process validations experience
o Deep understanding of Quality concepts, practices, procedures and regulations.
o Familiarity with a variety of document control systems and methods
o Ability to read, understand and implement document changes
o Quality Metrics experience
o Expertise with internal & external audits, including FDA and certified bodies
o Knowledge of relevant standards including ISO13485, 21 CFR Part 820 and ISO 14971
o ASQ Certification desirable (CQE, CBA, CQM, CRE, etc.)
Finally and critically, we seek a hands-on, make-things-happen leader; someone who brings ingenuity and initiative; someone who sees a need and fills it. A lot is happening. We seek a contributor who will thrive.
This is an immediate need. Please forward Word resume for prompt consideration. Local candidates only.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.