Quality Assurance Specialist

Quality Assurance Specialist

Join QIAGEN as a Quality Assurance Specialist and play a key role in supporting our Quality Management System within a regulated medical device and life sciences environment. The Quality Specialist will report to the Quality Assurance Manager. The position will represent Quality within cross-functional teams for assessing change needs, impacts, and quality management activities, as well as supporting organizational change activities. As such, the role interacts regularly with other departments, functional peers, and personnel at all levels within the organization. Position responsibilities also include monitoring change controls and data trending to provide corrective action solutions that drive continuous improvement.

Your tasks include

• Supporting the creation and maintenance of Risk Management documentation, including dFMEAs, pFMEAs, and Control Plans.
• Writing, reviewing, and approving equipment IQ/OQ protocols and assay verification and validation studies in collaboration with cross-functional teams.
• Conducting and supporting investigations of manufacturing nonconformities, identifying root causes, and implementing effective corrective and preventive actions.
• Managing and supporting complaint handling activities, including intake, evaluation, investigation, documentation, and reporting.
• Applying statistical methods to analyze data, monitor process performance, identify trends, and drive continuous improvement initiatives.
• Coordinating, analyzing, and distributing quality metrics while supporting internal, customer, regulatory, and supplier audits.
• Supporting change control activities, supplier evaluations, vendor audits, and compliance with ISO 13485, FDA regulations, and other applicable quality standards.

Your profile

• Bachelor's degree in a scientific or engineering discipline, preferably within Life Sciences, In Vitro Diagnostics (IVD), Medical Devices, or a related field; equivalent experience will also be considered.
• 2+ years of experience within an ISO 13485 and/or FDA-regulated medical device environment is preferred but not required.
• Knowledge of quality management principles, risk management methodologies, and regulated manufacturing environments.
• Experience collaborating with cross-functional stakeholders and effectively communicating with employees at all levels of the organization.
• Ability to manage multiple projects, priorities, and timelines while maintaining attention to detail and compliance requirements.
• Strong analytical and problem-solving skills, including the use of statistical methods for process evaluation and improvement.
• Professional certifications such as ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Lean Six Sigma, or similar credentials are highly desirable.

The estimated base salary range for this position is $65,000 - $78,000. Compensation will be based on the candidate's experience, skills, geographic location, and other job-related factors. In addition to base salary, we offer a total compensation package that includes a bonus plan and generous benefits.

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 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, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.