WE WILL RELOCATE YOU TO BEAUTIFUL ORANGE COUNTY, CA IF NEEDED....
We are a very well-established and publicly traded industry leader in the medical device manufacturing arena and with over 15 years of experience making some of the most quality products in the world, we are known for our excellence and high standards in product innovation. Our very talented and fun loving team is constantly expanding due to consistent growth and we are currently looking for a motivated Senior Quality Manager to join the team.
We offer an environment that fosters a true family oriented culture and with no egos over here, everyone’s opinion counts and this ideal along with our very attractive compensation and benefits packages coupled with a solid work life balance is just part of why we have such a tremendous retention rate of our employees.
If you are a Senior Quality Manager with experience managing or leading an FDA audit, please read on!Top Reasons to Work with Us1. Competitive compensation, attractive benefits including 401K and stock purchase program
2. Tremendous stability with a publicly traded industry leader in business for over 15 years
3. Opportunity for growth with within an incredibly fun and family oriented environmentWhat You Will Be Doing•Lead all aspects of quality support to North American commercial and distribution operations, including quality systems management, complaint management, product distribution quality and regulatory strategy support.
•Develop and implement quality strategies that achieve North American Operations, Global Quality & Regulatory and Global Supply Chain business objectives.
•Maintain and improve systems that ensure compliance to regulatory requirements (specifically US FDA).
•Lead, allocate and develop resources that achieve business needs.
•Manage and continuously improving the Quality Management System.
•Leading external and internal regulatory inspections / audits.What You Need for this Position•7+ years of experience in the medical device and/or pharmaceutical industries.
•Quality Management System experience
•Experience in global medical device distribution and/or manufacturing
•Experience with managing people
•Strong understanding of global medical device regulatory requirements (with specific expertise in US FDA QSR).
•Experience in managing external regulatory inspections / audits.
•Experience in attracting and developing talent to achieve a high performing team.
•Bachelor degree or equivalent in engineering, science, business, or similar.So, if you are a Senior Quality Manager with experience managing or leading an FDA audit, please apply today!
Applicants must be authorized to work in the U.S.
Preferred Skills quality management US FDA QSR Medical Device/Pharmaceutical
Location/Region: Irvine, CA (US)