Quality Manager

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Location: Irvine, CA US
Job Category: Quality & Regulatory Affairs
Position Description
Quality Manager

As we strive for continuous improvement and future growth, we are looking for an experienced, passionate, and dynamic Quality Manager to support continuous improvements in Quality and Regulatory processes that are compliant to Global Medical Device standards and requirements to achieve Vyaire business goals.

Together we are building the world leader in Respiratory Care and desire to attract and retain people who routinely distinguish themselves by their own performance, bring innovation, & push the status quo. Join us as we improve patient outcomes, advance the quality of care, and improve value for our customers.

In particular you can expect to:

  • Develop, implement, manage, audit and maintain Global GMP quality systems to support commercial and development activities for Vyaire products with sales in multiple countries.
  • Coordinate and perform or assist in, as needed, all compliance audits.
  • Develop, manage, and maintain a GMP compliant document control system.
  • Ensure that cGMP requirements and quality standards are recognized, understood and maintained.
  • Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines.
  • Budgetary and managerial responsibility for Quality Assurance and Doc Control.
  • Work across all disciplines (e.g. manufacturing, Operations, R&D, etc.) to ensure we maintain a state of readiness for inspection by regulatory agencies.
  • Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes.
  • Lead, manage, and ensure proper training to any relevant change management programs throughout the company.
  • Lead quality efforts in corporate development of analytical methods and provide quality guidance to product development projects and programs.
  • Represent QA at senior management, project, Board, and review meetings.
  • Serves as site management representative.

You will have the opportunity to:

  • Improve patient outcomes
  • Meaningfully impact the company‚Äôs short-term and long-term success
  • Work closely with executives across the organization
  • Grow your role as you see fit
  • Learn everything there is to know about respiratory medical device manufacturing
  • Create an inspiring workplace

To be successful, you will need:

  • Quality professional with 10+ years of hands on experience with increasing responsibility in a QA function.
  • Prior responsibility for Quality Assurance with an ability to critically evaluate and troubleshoot complex problems is essential.
  • Significant hands on experience in a Class II/III medical device or biopharmaceutical company, including clinical and commercial products.
  • Hands on experience implementing quality systems in a GMP environment, and direct experience with FDA and other health authority inspections.
  • Extensive knowledge of US GXP compliance regulations and industry practices, as well as EU & International standards and country specific requirements.
  • Strong hands on leadership and management skills with an ability to effectively participate on multi-disciplinary teams.
  • Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.
  • Well-organized and detailed oriented professional, with strong verbal and written communication skills.
  • Need to be ready to live and embrace the Vyaire Vision and Culture of the company.
  • To perform this job successfully, an individual should have complete knowledge and practical use of Microsoft office applications.        
  • Experience with SAP or Similar ERP Systems is preferred.
  • Experience with eQMS software solutions is preferred.

Education:

  • Degree (advanced degree preferred) in Quality Management or Engineering or relevant scientific discipline.

Some logistics:

  • Travel up to 20%
  • Location: Irvine, CA or Mettawa, IL

Irvine, CA, Mettawa- HQ

Full time
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