Synergy Bioscience has 3 openings for a Quality System Consultant (CAPA Process SME) with one of our clients in the medical device industry. This is a 12 month project. Our client is known for their innovation and outstanding work environment. This role will be responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. You will interact with many different functional departments, suppliers, and experts to implement Quality System remediation activities.
Typical Responsibilities for the CAPA Consultant job include, but are not limited to the following:
• Developing procedures, Root Cause Analysis tools, and training material for the CAPA process according to the regulatory requirements and standards.
• Providing training on the CAPA process to the client staff.
• Developing and implementing corrective and preventative action plans.
• Providing coaching and mentoring to the client staff members who are performing the investigations.
• B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE)
• 7 – 10 years of experience in quality system remediation or a similar role, an equivalent combination of education and experience may be considered.
• Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Able to communicate both orally and in written form to multiple levels of the company.
• Demonstrates characteristics of high potential for future development opportunities.
• Clear understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods as they pertain to the medical device industry.
• Only candidates with outstanding track record of success will be contacted for interview.
• Highly competitive hourly rate based on experience.
• You will be reimbursed for the expenses during the duration of the project (Air flight tickets, Rental Car, Hotel, meals).