Director of Quality/Regulatory

PLC Medical Systems, a small entrepreneurial Medical Technology Company on the 495 beltway, is expanding past its current commercial product line into a whole new line of Technology focus in a whole new market. The company is a well-established, cardiovascular device company who is in the prototype stages of developing a new cutting edge application using standard technologies in a very unique way. As a result of these new initiatives we are seeking to fill the following newly created, key, hands on position:

Director of Quality/Regulatory

 

This is an excellent opportunity for a seasoned, hands on medical device QA/RA executive to further and lead significant quality programs.  As the Director of Quality you will lead the company?s quality program strategy and implementation, and ensure that all program deliverables and elements of the strategy are met.

 

You will assume a leadership role in all aspects of a global Quality program for the company?s products, 13485, design, CAPA and government regulatory issues as they relate to quality.  You will develop and oversee the quality objectives for the Product Realization process and the overall of the company.

 

Ensure compliance of the Company?s quality systems to regulatory requirements: including but not limited to Quality Systems Regulations (USA), and ISO (CANADA & EUROPE), Japan.

Prepare the product and process for PMA, 510k, GMP and CE Mark audits.

Manage internal audit system strategy to verify the quality system evolution, including special investigations.

 

Develop and execute departmental objectives for the improvement of corporate quality systems including:

?  Preparing and obtaining approval of Quality Assurance budget

?  Managing customer complaint and correction process (CAPA)

?  Raise the field quality issues to the organization and lead the resolution process

?  Manage the company sterile product process with its subcontractors.

 

Requirements Include:

 

Minimum of ten years experience in the medical device industry, with a focus on the Quality/Regulatory Management function

 

BS or MS in Engineering or closely related health sciences degree

Extensive medical device QA experience, ideally in cardiovascular or other Class 2, 3 devices

 

Experience leading a multidisciplinary team in test protocol design and execution and analysis as well as developing and executing quality objectives for product development and manufacturing of medical devices 

 

A proven track record in the successful completion of quality (ISO or QSR) audits and inspections

 

Must be knowledgeable about Sterile Product requirements

 

Demonstrated ability in leading teams through quality system development in scale up manufacturing environment

 

Knowledge of relevant regulations (EN, GMP and ISO)

 

Demonstrated ability to understand and interpret statistical analyses

 

Ability to innovate and manage within a dynamic environment, and work well with other departments

 

Demonstrated ability in process evolution to improve and simplify processes

 

Experience implementing and managing effective and engaging training procedures

 

Excellent problem solving skills

 

Strong interpersonal and communication skills (oral & written)

 

Ability to function in a self-directed manner with a high degree of independence

 

Demonstrated ability to work in a hands on environment with limited resources

 

PLC offers an exceptional competitive salary and benefit package including medical, dental, life, disability, FSA, 401(k), EAP, paid time off, and tuition assistance in a smoke free, business casual environment.

To apply for this position please send your resume, along with your salary requirements to: kpapa@insightperformance.com or FAX it to: (781) 326-6048. Please include CODE: QA

(NO RELOCATION WILL BE PROVIDED - LOCAL CANDIDATES ONLY PLEASE)