Quality Assurance Specialist

QIAGEN•Beverly, MA

26d•$65,000 - $78,000•Hybrid

About The Position

At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams. We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you. At QIAGEN, every day is an opportunity to make a real-life impact. Join us, grow with us, and together, let's shape the future of biological discovery. 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.

Requirements

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.
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.

Nice To Haves

2+ years of experience within an ISO 13485 and/or FDA-regulated medical device environment is preferred but not required.
Professional certifications such as ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Lean Six Sigma, or similar credentials are highly desirable.

Responsibilities

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.