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Director of Quality Systems

Real Staffing

Location:
San Francisco, CA
Posted Date:
7/22/2014
Position Type:
Full time
Job Code:
77355.90343
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Client:

The Client is a global medical device and diagnostics company with a broad portfolio of products and solutions. They are the industry leader in blood management solutions.

The Role:

As Director of Quality Systems you will direct: CAPA, Complaints, Environmental Programs, Sterilization, Management Review, Change Control and Design Review. You will play a cross-functional role working side by side with Manufacturing, Quality Engineering and Software Solutions Quality. Maintain alignment of the Quality System in support of the Company's business goals.

Responsibilities:

  • Implementation and maintenance for Quality System and compliance program requirements- MDD 93/42/EEC, ISO13485, CMDR
  • Align Quality strategy throughout the region
  • Provide Management with evaluation of overall Quality and Regulatory performance and provide guidance
  • Proactively identify and resolve quality issues and ensure compliance to written specifications.
  • Develop Quality Systems professional develop in Quality and Regulatory
  • Educate employees on Quality Systems regulations.
  • Main representative in 2nd and 3rd party quality system audits and investigations- FDA, ISO, Customer, Contractor
  • Develop and implement effective CAPA and Continuous Improvement programs using Six Sigma and Lean tools/programs

Requirements:

  • Bachelor's Degree- engineering, life sciences or business
  • 10+ years Quality Assurance experience
  • 7+ years Management experience
  • Strong knowledge of ISO-13485, EEC, CMDR
  • Strong knowledge of Six Sigma and/or Lean
  • Strong Communicator

Requirements

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