DIRECTOR OF QUALITY SYSTEMS and REGULATORY COMPLIANCE

DIRECTOR OF QUALITY SYSTEMS and REGULATORY COMPLIANCE

Our client, a leader in the Medical Device/ Pharmaceutical industry and in applying the principles of biotechnology to medical devices has built a fully integrated medical device company with thousands of products for a number of medical specialties.  They are experiencing significant growth and are in search of a Director of Quality and Regulatory
Compliance

SUMMARY DESCRIPTION


Directs, coordinates and evaluates the activities of the plant site Quality System and regulatory compliance programs.  Ensure the development, manufacture and distribution of medical products in compliance with corporate policies, U.S. FDA regulations, ISO 9001, ISO 13485:2003, the Canadian Medical Device Regulations (CMDR), the Medical Device Directive, and other applicable regulatory agencies. 

RESPONSIBILITIES

• Direct the activities of the site regulatory compliance program to ensure compliance with all appropriate regulations and standards, including FDA, ISO 9001, ISO 13485:2003, CMDR, and MDD.
• Ensures the Quality System is established, implemented and maintained in compliance with all applicable FDA Quality System Regulations, ISO 9001, ISO 13485:2003, the Medical Device Directive (93/42EEC), and the Canadian Medical Device Regulations (CMDR).
• Oversee Internal Audit program and the audit program corrective actions
• Coordinates the external audit program and management of external audit corrective actions Participates in Product Quality reviews, Management Reviews and preparation of Quality reports.
• Ensure that all corrective actions from internal and external audits are effective and verified.
• Review and approve Engineering Change Orders, nonconformance reports, and validations for the facility.
• Participate in review of product labeling as required
• Coordinates and Participate in FDA inspections, ISO certification and customer audits.
• Participate in evaluation of new product opportunities at the Plainsboro facility. 
  Identify and implement opportunities for continuous improvement.
• Coordinates all quality issues with private partners and is the primary contact for all quality issues with private partners.

DESIRED MINIMUM QUALIFICATIONS

• Bachelors or Masters Degree in Engineering or related scientific discipline
• 10 + years of experience in Quality Assurance and/or Engineering in manufacturing positions in the medical device industry;
• Minimum 3 years should be in a Quality Leadership Role in a medical device company.
• Extensive understanding of FDA regulations, ISO 9001, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards.
• Lean Manufacturing, and Six Sigma working knowledge preferred
• Experience as the lead liaison for FDA and ISO audits/inspections
• Extensive knowledge and experience in validation process design and implementation, change control, auditing document management systems
• General knowledge of statistical analysis.
• Experience in developing and executing training programs

COMPENSATION

140K base salary, (Compensation commensurate with experience and salary history), annual target bonus, benefits package and relocation assistance. 
     
       
For confidential consideration, please forward your resume in a Word document to
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