Quality Compliance Manager

Are you a Quality Manager who has a background in either the medical device or the aerospace industry? Are you a Quality Manager who wants to focus on all aspects of ensuring FDA compliance? Are you a Quality Manager who wants to join a company that over the pat three years has increased sales 20-30% each year? If you can answer "yes" to these questions, then you should consider this opportunity.
Our client is a privately held company that truly value its employees. The company's culture is relaxed, but yet people work hard while also having fun. The company is a job shop running a two shift operation. Our client sells to the medical device industry, and business is very strong. Over the past three years our client has seen tremendous growth year over year, and our client has almost doubled its workforce. As Quality Compliance Manager you will need to adapt the Quality System to meet customer expectations and ensure FDA compliance while managing a team of up to six.
In this role your focus will be on compliance, and your responsibilities will include:
Overseeing the design and training of the company's Quality Procedures, Standards, and Specifications in conjunction with the "Quality Policy."
Reviewing customer requirements and ensure that they are being met
Administering quality requirements to external supplier along with coordinating internal and external auditing schedule
Managing and prioritizing the activities of the quality team
Assisting in Material Review Board meetings
Facilitating management review to satisfy ISO 13485 and FDA requirements
Meeting with the appropriate individuals in the company to address change control within the organization
Coordinating Engineering Change requests
Your background should include:
Minimum of 5 year of experience as a Quality Manager
A background of progression through the Quality Department that ideally began as a Quality Tech/Inspector
Solid experience in either the medical device or aerospace industry
Strong compliance experience and a desire to focus on the compliance area
Strong customer relations experience
Strong experience working with suppliers
Experience managing quality systems
Experience managing a quality team in a very hands-on environment a plus
ISO experience required. FDA experience plus
FMEA experience
Our client is searching for only local/commutable candidates as there is no relocation assistance offered.

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