Senior Quality Manager
Location: Onsite - based in their of our clients locations: Alden / Buffalo and Minneapolis
Contract: 6 – 9-month contract, full-time.
Trinzo is a Medical Device and Pharmaceutical consultancy firm based in Galway, Ireland that specializes in providing our clients, who are Global Leaders in the Medical Device and Pharmaceutical Industry with Quality, Compliance, Regulatory and Project Management experts.
Our client, one of the largest Medical Device Manufacturers in the world are seeking an experienced Senior Quality Manager to help lead a team in the day-to-day operations. We are seeking Senior Quality Managers for three locations: Alden / Buffalo, Minneapolis & Uruguay. For the Uruguay location, you need to be fluent in both English and Spanish.
- Lead a team of Engineers on day-to-day operations such as CAPA and NCRs.
- Provide support for New Product Development launches.
- Deal with any Risk Management issues that are associated with Regulated Products.
- Help drive site Quality Metrics such as Complaints, CAPA’s, NCR’s and Cost of Quality.
- Provide support for Quality Culture.
- Support and help make key decisions regarding Quality as you would be the Quality Management Representative.
- Liaise with suppliers, customers and regulatory bodies when the need arises.
- Working to ISO, GMP, GDP standards.
- Bachelor’s degree in Engineering, Math or Statistics. Master’s degree preferred.
- ASQ certification preferred.
- Regulatory Affairs Professional Society (RAPS) medical device certification preferred.
- At least, 10-12 years of experience in quality or technical functions within the medical device industry, with 3-5 years in managerial experience.
- Project management, team development, and management skills
- Excellent written and oral communication skills; ability to communicate effectively to Executive level staff; experience with verbal and written communication to FDA and to customers; strong technical writing skills.
- Strong leadership skills with demonstrated ability to drive positive results.
- Experience with Class III & Implantable devices is an advantage.
- Ability to assimilate and analyse information efficiently and apply critical evaluations.
Trinzo’s Core Values:
- High performance.
- Value focused.
- Positive, can-do attitude.
- Gratitude and humility.