Vice President of Quality Assurance

San Francisco  ‐ Onsite
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Keywords

Description

The Company is an early stage Class II medical device developer.

As Vice President of Quality Assurance you will own all of the Quality activities including document control, internal external auditing programs, non-conforming reports. You will have a strong focus on efficient and timely approval of devices using your creativity to balance business needs and regulatory compliance. Overall responsibilities include setting and achieving Quality goals, developing and improving all aspects of the Quality System and Product Quality.

Essential Duties:

Management:
  • Serve as key member of Senior team to ensure Quality functions are aligned with overall business objectives.
  • Work closely with Executive team- Engineering, Project Management, Marketing, Quality and Regulatory.
  • Coach and mentor Quality organization to assure continuous awareness and improvement of the Quality System and group


Quality Assurance:
  • Develop Quality System strategy from early stage to commercializing for Class II Medical Device.
  • Ensure Quality System Compliance to ISO-13485
  • Assess and Implement 21 CFR 820
  • Assess and Review Document Control process and documents for quality and regulatory compliance.
  • Support and assure completion of Internal and Extenal Audits.
  • Issue, manage, and close CAPA with effecting root cause analysis
  • Implement and manage Design Control or Change Control
  • Document Control, DHF, DMR
  • Supplier evaluation and audits


Qualifications:

Must have:
  • At least 10 years of strong Quality Systems leadership in Medical Device
  • B.S. in Life Sciences or Engineering
  • Mastery of medical device regulations (ISO 13485 and 21 CFR Part 820 Medical devices; CGMP)
  • A solid auditing background
  • Experience in project management
  • Familiarity with medical device design control processes
  • Experience in quality management system implementation
  • Experience brining device to commercialization
  • History of working effectively in a highly cross-functional and collaborative environment
  • Excellent verbal and written communication


Preferred:
  • M.B.A. or other relevant advanced degree
  • Start-up experience
Start date
07/2014
From
Real Staffing
Published at
02.07.2014
Project ID:
735067
Contract type
Permanent
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