Site Quality Manager - Medical Device - Hopkinton, MA
This is an opportunity to work for a global healthcare leader.
You will oversee the entire Quality department.
About Our Client
Our client, a leading medical device company, is currently seeking an accomplished Quality Manager to join the team.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Quality Manager will be responsible for the following:
- Ensure that the site is compliant with applicable quality and regulatory requirements
- Support FDA and customer audits as well as manage CAPA
- Ensure that each finished product disposition reflects company's commitment to integrity and quality
- Review, revise, metrics and develop and manage programs required to support and drive improvements in company's systems and operations
- Manage current quality systems to include CAPA, Change Control Deviations, Audits, Annual Product Reporting
- Investigate consumer complaints and in-house generated excursions
The Successful Applicant
The following are some of the requirements for this role:
- Bachelor's degree in Science, Engineering or a related field.
- Minimum 5 years of recent and relevant medical industrial experience or business experience.
- Possess an auditor certificate from a recognized organization is a plus
- Strong background and knowledge of engineering and technical applications used in the development of medical devices. * Global Regulatory Affairs background, including MDD / IVDD.
- Experience in FDA 510(k).
- Proactive attitude and excellent organizational skills.
- Effectively react in stressful situations and make clear, well-founded decisions regarding conformity during the audit.
What's on Offer
Here are a few examples of what you'll get for the great work you provide
- Full range of medical benefits, dental, vision
- Life Insurance