Director of Quality Assurance

US$240000 - US$260000 per annum + Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
San Jose, USA
Posting date: 25 Mar 2024

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Director of Quality Assurance - Permanent - Onsite

Proclinical Staffing is seeking a Director of Quality Assurance to join an innovative medical equipment organization. This is a permanent role located in San Jose, CA.

Skills & Requirements:

  • 2-4 years as a Sr. Manager of Quality (special focus on design and customer quality), Design Assurance and/or R&D function or equivalent experience
  • Previous experience at the Director level preferred but not required BS in Engineering or other relevant field of study
  • Minimum of 10 years experience in a manufacturing and product development environment (Medical Device experience highly desired)
  • Prefer 15 years full time work experience Master's Degree or equivalent preferred.
  • Six Sigma experience, CQE/CQM/PE certification preferred.
  • Formal training in Quality Systems.
  • Must be able to communicate with large groups of people.
  • Must be able to review printed materials.
  • Must be able to generate and explain detailed proposals, guidelines, and procedures for the Quality function to departmental and/or non-departmental personnel.
  • Must be able to analyze and resolve non-routine product issues using independent judgment.
  • Must be able to routinely make decisions which affect immediate operations and may have a company-wide effect.
  • Must be able to observe and correct minute inconsistencies (e.g. in the printed word, a production process, product appearance, etc.).
  • Must be willing to travel (25%) and spend time in the operating room, cadaver and animal labs and visit customers or teams in other geographies as needed
  • Excellent analytical skills.
  • Excellent interpersonal skills.
  • Demonstrated effective managerial skills.
  • Excellent organizational skills.

The Director of Quality Assurance will:

  • Provide a strategic direction and tactical focus to the Quality Assurance organization and influence the direction of divisional QA activities (specifically Design and Customer Quality)
  • Own cradle to grave (Pre and Post Market) from New Product Development to obsolescence, quality of all products in the business
  • Launch new products with high quality and ensure quick resolution to quality issues on launched products as well as work closely with several functions including salesforce, marketing, R&D, product engineering, field service, operations, Project management etc.
  • Ensure that manufacturing, product development, and related functions are conducted in compliance with international standards and government regulations in support of company mission.
  • Establish standard process to ensure appropriate resolution and management of the responsible task owner.
  • Chair meetings required to drive closure of quality issues.
  • Manage and provide updates for quality metrics.
  • Implement appropriate enhancements.
  • Review regulatory compliance requirements for changes affecting device manufacturing in global markets.
  • Support quality system changes to support evolving regulations and international standards.
  • Represent quality processes during internal and external audits.
  • Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
  • Recruit, select, and on-board top talent.
  • Develop talent within team to increase performance.
  • Actively address performance issues on team.
  • Maintain a high level of team engagement.


$240,000 - $265,000 annually

If you are having difficulty in applying or if you have any questions, please contact Julia Ahadi at (+1) 512-643-4324 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.