Growing Orthopedic Company seeks a Supplier Quality Engineer. This person will provide Engineering Support and Guidance for the company’s product line. Must have MEDICAL DEVICE EXPERIENCE. Must have MINIMUM 5+ years of experience.
This person will support the activities of QA/RA Management. This position helps ensure that the company complies with and meets the standards of regulatory agencies as necessary.
Duties and Responsibilities
- Develop and maintain an understanding of the requirements regulatory jurisdictions, as applicable, to help the company lead the Medical Device and Biologics industries in quality practice
- Develop and maintain an understanding of the products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
- Manage Supplier Qualification activities, including but not limited to, initial qualification, re-qualification, SCAR issuance, supplier qualification termination, etc.
- Plan and conduct regular audits with suppliers including onsite qualification of product and processes. Write audit reports to disclose findings as needed. Maintain and update critical supplier audit system and schedule
- Support new supplier evaluation and qualification including inspection and first articles
- Measure, analyze, and improve supplier performance and reduce supplier nonconformances
- Work to resolve supplier technical issues in a timely manner to ensure continuity of supply
- Conduct receiving inspections, in-process inspections and finished device inspections
- Inspecting and monitoring receiving, in-process, and final product control results including collection and testing of representative samples
- Participate in and help lead successful external audits (FDA, ISO, etc.). Serve as a liaison between QA/RA Management and the auditor(s) during regulatory inspections
- Perform and participate in validations as needed
- Participate in design control as needed
- Help to accomplish quality objectives and develop quality standards
- Submit timely expense reports and abide by the Expense Reimbursement Policy
- Complete required training prior to performing tasks, including initial orientation and environmental health and safety training. Keep training up to date
- Train and supervise the training of others in Department activities
- Bachelor's degree in biology-related, engineering or an equivalent course of study is required
- Five plus (5+) years’ experience in medical device, biologics, orthopedic or health industry quality assurance is preferred
- Corrective/preventive action, root cause analysis, effectiveness check, statistical application experience and training is required
- ISO 13485 Lead Auditor Certificate is preferred
- ASQ Certified Quality Auditor Certificate is preferred
- Six-sigma black-belt certification is preferred
- General knowledge of ISO 13485 and FDA Quality System Regulation guidelines required, advanced knowledge is preferred
- Regulatory and Quality auditing training and experience is required
- Experience and high level of proficiency in Microsoft Office Suite is required
- Experience with records maintenance and document control
- Experience in regulatory standards, regulatory inspection hosting, GLP, GMP and GDP
Position based in the West but will be remote.
For more information please send an updated resume to firstname.lastname@example.org. Qualified candidates will be contacted promptly.