Director Quality Assurance
Company: QIAGEN Gruppe
Location: Ann Arbor
Posted on: November 22, 2021
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
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
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
- 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
- Hire and develop Quality Assurance staff.
- Maintain a Quality System consistent with current FDA and ISO
- Develop, and maintain QA metrics to track performance of the
quality system and drive process improvements.
- Manage GxP Documentation & Review program consistent with
- Ensure the compliant release of product batches/serial
- Coordinate internal and external (supplier and/or contract
manufacturing organization) audit programs.
- Manage and lead Failure Mode investigations, CAPAs,
- Effectively represent NeuMoDx to local, corporate, and
- 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
- Proven experience in IVD industry and working knowledge of
statistical process control & sampling techniques are strongly
- 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 Benefits@QIAGEN.com . 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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