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Director Quality

Location: PA
Industry: Medical Device
Job Code: 12024-06

Requirements:

• Advise employees up to executive management team, on the FDA QSR requirements, ISO 9001:2000 standards, companies policies.
• Direct the overall Quality Management System and quality initiatives and drive their implementation and deployment.
• Work with Med QT and other groups to develop standard processes that conform to company's standards and to the FDA Quality System Regulations.
• Lead the develop of documentation (Policies, SOP's, Work Instructions, and Training) to support and drive the development and improvement of the 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.
• Assess the Quality System for compliance to FDA Quality System Regulations, ISO standards, and company's policies and procedures through internal and external audits.

 

Qualifications:

• Minimum of a Bachelor’s degree, Six Sigma Black Belt preferred or a Green Belt at a minimum
• Must have at least 10+ years of progress people and process management experience within a Medical Device organization.
• Certifications and Memberships through ASQ and RAPS are desired
• Must have prior management experience
• At least 10 yrs medical device quality systems experience
• Well versed in ISO 9001 and FDA's QS regulations

Please Note: We are not looking for Quality Assurance people who have mostly involved with QA from a production stand point. We are looking for someone with quality systems experience.

Contact:

For more information on 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@regexec.com.

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