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

BD; Zürich; Vor Ort; CHF 97.000 - 147.000; Vollzeit

Zusammenfassung

BD is seeking a Quality Engineer (m/w/d) for Validation & Risk Management in Wangs, Switzerland. The role focuses on establishing quality control systems, setting product requirements, and identifying defects within a global medtech context.

The successful candidate will drive FMEAs, risk management, and method validation, collaborating across cross-functional teams to ensure ISO 13485 and MDR compliance. Fluency in German and English, plus an engineering degree, are mandatory.

Qualifikationen

• Bachelor's degree in engineering, preferably mechanical or process engineering, materials science, chemical or pharmaceutical engineering
• Practical knowledge of global regulations and standards for medical devices (ISO 13485, ISO 14971/24971, MDR)
• At least 3 years in medical devices or similar regulated environment with knowledge of regulatory requirements and quality systems
• Fluent German and English with written skills (mandatory)
• Good analytical skills
• Process-oriented with high accuracy
• Ability to work in multidisciplinary and international teams
• Knowledge of MS Office (Word)
• Knowledge of Design of Experiment (DOE) and Minitab software

Aufgaben

• Support quality development activities for commercial production
• Ensure compliance with quality system requirements (ISO, MDR, FDA where applicable)
• Collaborate with Manufacturing Engineering on FMEAs and risk management documents
• Support validation/re-validation of test methods and processes
• Develop, review and approve validation protocols and reports
• Assist Manufacturing Engineering with quality-related tasks
• Carry out statistical analyses to assess process capability
• Support IQ/OQ/PQ activities and protocol/report reviews
• Contribute to CAPAs and root-cause analyses
• Act as quality expert in regulatory audits

Kenntnisse

German language

English language

Analytical skills

Process orientation

Multidisciplinary teamwork

MS Office

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

DOE

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