Senior Quality Manager
Senior Quality Manager
Location: Onsite - based in their of our clients locations: Alden / Buffalo and Minneapolis
Contract: 6 – 9-month contract, full-time.
About Trinzo:
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.
Role Responsibilities:
- 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.
Role Requirements:
- 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.
- Teamwork/collaboration.
- Positive, can-do attitude.
- Gratitude and humility.
- Trusting.
- Department
- Quality
- Locations
- USA
USA
Our Company Culture
People First, Always
Trinzo is a company driven by unshakeable core values: we put people first, from our consultants to our clients, and we value hard work, honesty and integrity above all.
At Trinzo, we strive to create a company culture that encourages each member of the consultancy ecosystem to reach their fullest potential, whether that’s a client with an organizational issue or a consultant with a vision for change.
We help our team to lead the industry in creating solutions, applying well-tested methodologies and persistently seeking innovative ways to help our clients succeed.
About Trinzo
Trinzo is a medical device and pharmaceutical consultancy firm that excels at compliance, regulatory and project management issues. We create bespoke solutions for our clients on a project basis and find the root of structural issues.
In many cases, our clients hire us to solve a specific problem or remediate an issue. Sometimes, the issue at hand is only surface-level and our knowledgeable consultants use their industry expertise to design a comprehensive solution. But when the challenges run deeper, Trinzo will get to the heart of the issue, offering insight, advice and industry-leading methodologies that will leave your team stronger, with renewed motivation and increased efficiency.
Senior Quality Manager
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