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Director Quality Assurance

Company: QIAGEN Gruppe
Location: Ann Arbor
Posted on: November 22, 2021

Job Description:

At the heart of QIAGEN's business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.--
Our most valuable asset are our employees - more than 5000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day. Position Description As a member of the senior operations team, the Director, Quality Assurance will have the opportunity to manage an efficient quality system and team of quality professionals to ensure compliance of the company's GxP policies with evolving federal and international regulations & standards. In this position, you will be responsible for leading companywide quality management efforts, in support of product and process quality, through product development, clinical validation, and product commercialization phases.

  • Develop Quality strategy for the organization.
  • Ensure best practices are employed when developing and improving quality processes.
  • Drive continuous improvement in Quality and Operations processes across the organization.
  • Ensure that processes and procedures and aligned with global corporate procedures and policies.
  • Actively participate in strategic corporate quality initiatives.
  • Hire and develop Quality Assurance staff.
  • Maintain a Quality System consistent with current FDA and ISO regulations/standards.
  • Develop, and maintain QA metrics to track performance of the quality system and drive process improvements.
  • Manage GxP Documentation & Review program consistent with appropriate regulations.
  • Ensure the compliant release of product batches/serial numbers
  • Coordinate internal and external (supplier and/or contract manufacturing organization) audit programs.
  • Manage and lead Failure Mode investigations, CAPAs, Non-Conformances etc.
  • Effectively represent NeuMoDx to local, corporate, and regulatory agencies
  • May serve as Management Representative. Position Requirements
    • B.S in Life Science or Engineering discipline with a 7+ years' experience in a Quality Assurance/Quality Systems management position in the Medical Devices, IVD, or Biotech industries.
    • Expert knowledge of FDA QSR, ISO 13485, and ISO 14971 with emphasis on product development, process validation, failure investigations, CAPAs and NCRs.
    • ASQ certified CQE and a certified auditor is a strong plus.
    • Proven experience in IVD industry and working knowledge of statistical process control & sampling techniques are strongly desired.
    • Ability to train inter-disciplinary teams in quality processes, procedures, and adherence.
    • Proficiency with Microsoft Word, Excel and PowerPoint for data analysis and report generation is a must. Personal Requirements
      • Demonstrated experience working with cross-functional groups (R&D, Operations, Clin/Reg, etc.) requiring strong inter-personal skills, excellent communication skills, and the ability to work well under pressure. QIAGEN requires proof of full COVID-19 vaccination as a condition of employment for new hires in all U.S. states other than Montana effective as of September 1, 2021. New hires and candidates will be required to present proof of full COVID-19 vaccination within three business days of start date or upon entry into the office (i.e., for interviews), whichever comes first. QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact . This policy is part of QIAGEN's ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community. What we offer At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

        QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

Keywords: QIAGEN Gruppe, Ann Arbor , Director Quality Assurance, Executive , Ann Arbor, Michigan

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