Senior Manager QA Software Compliance (f/m/d)

QIAGEN; Hilden; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading biotech firm in Hilden seeks an experienced professional for a software quality assurance role. Responsibilities include ensuring compliance with IVDR and FDA regulations, supporting development teams, and conducting audits. The ideal candidate has at least 5 years in the medical device sector, knowledge of quality management systems, and proficiency in English. Benefits include holiday pay, hybrid working, and additional perks.

Leistungen

Holiday pay and extra days off

Hybrid working

Bicycle leasing

Gym and free sport classes

Company pension scheme

Subsidized lunch

Childcare options for children under 3

Internal training opportunities

Free parking

Employee Assistance Program

Qualifikationen

• 5+ years of relevant experience in software lifecycle management.
• Solid knowledge of IEC 62304, IVDR, FDA 21 CFR 820, ISO 14971.
• Experience with FDA premarket guidance and EU MDR/IVDR expectations.

Aufgaben

• Support compliance with internal procedures and external regulations.
• Review and approve software development documentation.
• Conduct internal audits and contribute to regulatory inspections.

Kenntnisse

Software lifecycle management

Quality management systems knowledge

Cybersecurity compliance

JIRA proficiency

Strong English skills

Ausbildung

Degree in computer science, bioinformatics, biology, or a related field

Tools

Polarion

Jobbeschreibung

Overview

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 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.

Position Description

We are seeking an experienced and motivated professional to join our software quality assurance team. In this key role, you will help ensure compliance with IVDR, FDA 21 CFR Part 820, and cybersecurity requirements for medical device software.

• Partner with development teams to support compliance with internal procedures and external regulations
• Review and approve software development documentation in international, cross-functional project teams
• Safeguard adherence to Design Controls and regulatory requirements
• Identify and address deviations, support corrective actions, and promote continuous process improvement
• Conduct internal software audits and contribute to audits / inspections by regulatory authorities

Position Requirements

• Degree in computer science, bioinformatics, biology, or a related field – or 5+ years of relevant professional experience
• At least 5 years in software lifecycle management within the medical device or IVD industry
• Solid knowledge of quality management systems and standards (IEC 62304, IVDR, FDA 21 CFR 820, ISO 14971)
• Experience with cybersecurity compliance (FDA premarket guidance, EU MDR / IVDR expectations)
• Proficiency with tools such as JIRA and Polarion
• Strong English skills; German is an advantage

What we offer

• Holiday pay as well as additional days off on Christmas Eve, New Year\'s Eve & Carnival Monday
• Hybrid working (depending on your role)
• Bicycle leasing
• Gym & free sport classes
• Company pension scheme & employer contributions to a savings plan
• Subsidized lunch
• Possibility for childcare for children under 3 (QIAkids)
• Internal training opportunities
• Free parking
• Employee Assistance Program and internal QIAGEN communities

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 creatingan inclusiveenvironment 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.