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Director, Quality Assurance

Location: PA
Industry: Medica Device
Job Code: 12024-13

Description:

Our client has asked us to identify candidates for this leadership role to advise staff on the FDA QSR requirements, ISO 9001:2000 standards, and company policies. They will direct the overall Quality Management System and quality initiatives and drive their implementation and deployment. Lead the develop of documentation (Policies, SOP's, Work Instructions, and Training) to support and drive the development and improvement of groups Quality System.
• Ensure the development of the Quality team through mentoring and coaching.
• Partner with Strategic Purchasing and Service Vendor Management to define, implement and enforce policies, procedures and practices for supporting the supplier management program.
• Identify and direct activities to ensure Organizational compliance to the FDA Quality System Regulations and Siemens internal policies and procedures.

Qualifications:

• Applicants must be well versed in ISO 9001 and FDA's QS regulations.
• At least 10 yrs medical device quality systems experience (*not looking for quality experience from a production standpoint)
• Minimum of Bachelor's level degree. Six Sigma Black Belt preferred or a Green Belt at a minimum.
  - Certifications and Memberships through ASQ and RAPS are desired
• Candidates must possess 10+ years of progressive people and process management experience within a Medical Device organization.
  
  

Contact:

For consideration for this or any of our other available positions or to be contacted by one of our staffing specialists, please send us your resume, cover letter and RegExec job code to resume.

PLEASE NOTE: All resumes that are received by RegExec will be thoroughly reviewed by one of our staffing specialists and treated confidentially.