This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Support with end-to-end External Manufacturing and Supplier Quality activities, including but not limited to: process validations, manufacturing site transfers, NC/CAPA root cause investigations, Change Control, Supplier Quality Agreement updates, Approved Supplier List (ASL) updates, metric analysis and reporting, process improvements
Provide sound, risk-based QA direction and independent and timely decision-making on a wide range of quality and compliance issues
Ensure compliant execution of Quality Management Systems
Provide leadership across activities associated with supplier risk identification & management
Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements under limited supervision
Adaptable and flexible for other duties that may be assigned as needed
Requirements:
A minimum of a Bachelor's or equivalent University degree
a concentration in Engineering or related scientific field is preferred
A minimum of four (4) years of relevant work experience
Experience leading and owning investigations, NCs, CAPAs or deliverables
Critical thinking skills
Excellent written and verbal communication skills with attention to detail
Hands on production line experience
Medical device experience
What we offer:
Medical, dental, vision, life, disability, and other insurance plans
ESPP (employee stock purchase program)
401K program with company match after 12 months
HSA (Health Savings Account on the HDHP plan)
SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions
Corporate discount savings program
On-demand training program
Access to certification prep and a library of technical and leadership courses/books/seminars after 6+ months