Quality Engineer (m/w/d) Medical Devices – Validation & Risk Management - English & German

BD; Vilters-Wangs; Vor Ort; CHF 97.000 - 147.000; Vollzeit

Zusammenfassung

BD in Wangs, Switzerland is seeking a Quality Engineer (m/w/d) in medical devices focused on validation and risk management. The role requires conducting quality development activities, ensuring compliance with ISO and MDR standards, and collaborating with cross-functional teams including Manufacturing Engineering.

The ideal candidate has a engineering degree, 3+ years in regulated environments, and fluent English and German.

Qualifikationen

• Bachelor's degree in an engineering discipline.
• 3+ years in medical device or regulated environment.
• Fluent English and German, written and spoken.
• Knowledge of ISO 13485, ISO 14971/24971 and EU MDR.
• Experience with quality systems and regulatory requirements.

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with quality system requirements and standards.
• Collaborate with Manufacturing Engineering on FMEAs and risk documents.
• Assist validation and qualification of test methods and processes.
• Support CAPAs and root-cause analyses.
• Act as quality expert in regulatory audits.

Kenntnisse

Analytical skills

German & English fluency

Process orientation

Team collaboration

MS Office

DOE

Minitab

Regulatory knowledge

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

MS Word

Jobbeschreibung

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

A Quality Engineer (QE) is responsible for determining production standards for the company’s products by establishing quality control systems and setting product requirement rules. Quality Engineers identify specifications and determine the appropriate level monitoring for quality assurance. Quality Engineers help create solutions as part of an engineering team. They work to find defects, determine the causes of those defects, and provide solutions to defected problems.

We are looking for a Quality Engineer (m/w/d) Medical Devices – Validation & Risk Management - English & German in Wangs, Switzerland.

Responsibilities

• Support in all quality development activities for commercial production.
• Ensuring and complying with the quality system requirements defined by internal procedures, the FDA, and applicable international standards (e.g. ISO, MDR, ASTM).
• Cross-functional collaboration with the Manufacturing Engineering department on FMEAs (design, production, user) and creation, maintenance, and approval of risk management documents
• Support in the validation/re-validation of test methods and processes
• Development, review and approval of protocols and reports for the validation of test methods
• Support the Manufacturing Engineering team in all quality-related tasks
• Carrying out statistical analyses to determine process capability indicators
• Support in the implementation of process qualification and validation activities (IQ, OQ and PQ), e.g. reviewing protocols/reports
• Support with corrective/preventive actions (CAPAs), e.g. carrying out root cause analyses and applying problem-solving techniques, as well as implementing corrective/preventive actions
• In regulatory audits, you are an expert in all quality-related functions

About You

• Bachelor's degree in an engineering discipline, preferably mechanical engineering, process engineering, materials science, chemical or pharmaceutical engineering
• Practical knowledge of the relevant global regulations and standards for medical devices, such as ISO 13485, ISO 14971/24971 and the European Medical Devices Regulation
• At least 3 years of experience in the medical device industry or a similar regulated industrial environment, with good knowledge of regulatory requirements and quality systems
• Fluent German and English and written skills (mandatory)
• Good analytical skills.
• Process-oriented and high level of accuracy
• Ability to work in a multidisciplinary and international team environment
• Knowledge of standard MS Office (especially Word)
• Knowledge of DOE (Design of Experiment) and the statistical software Minitab

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

CHE Wangs - Straubstrasse

Work Shift

CH STR Mgrs-Admins (Switzerland)

Salary Range Information

CHF96,700.00 - CHF147,475.00 CHF Annual