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Senior Specialist Quality Assurance

QIAGEN
Gdańsk, województwo pomorskie
1 tydzień temu
Overview


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 6000 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

  • Supervision and continuous improvement of Quality Management Systems (QMS), aligned with ISO 9001 and optionally ISO 13485 standards
  • Ensuring compliance of quality processes with applicable legal and regulatory requirements
  • Overseeing and approving quality-related documentation to maintain high standards of accuracy and integrity
  • Acting as an internal auditor and supporting audit readiness throughout the organization
  • Preparing the organization for external audits, including regulatory and customer audits
  • Developing and implementing effective corrective and preventive actions (CAPA)
  • Monitoring and analyzing key quality metrics to drive performance improvements
  • Conducting training sessions for employees on QMS topics and best practices
  • Collaborating closely with production and quality control departments to ensure quality objectives are met
  • Supporting product and process improvement projects from the quality assurance perspective
  • Managing and maintaining quality databases, both electronic and paper-based

Position Requirements

  • Readiness to work under limited contract of employment for 1 year
  • English at least B2 level
  • Experience in managing Quality Management Systems (ISO 9001; ISO 13485 as a plus)
  • Knowledge of regulatory compliance in quality assurance
  • Internal auditor experience and audit preparation skills
  • Strong background in corrective and preventive actions (CAPA)
  • Ability to analyze quality metrics and drive improvements
  • Experience in working with cross-functional teams, especially production and quality control

What we offer

  • Private medical care
  • Multisport card
  • Training and development programs
  • Flexible benefits platform
  • Language classes
  • Friendly atmosphere
  • Casual dress code

Please make sure to send an English version of your CV!

Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.

QIAGEN is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.


Job Reference: EMEA05083
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