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

Becton Dickinson; Vilters-Wangs; Vor Ort; CHF 97.000 - 147.000; Vollzeit

Zusammenfassung

Becton, Dickinson, and Company in Wangs, Switzerland is seeking a Quality Engineer (m/w/d) for Validation & Risk Management in the medical devices sector. You will support quality development activities, ensure compliance with ISO 13485, ISO 14971, and MDR, participate in FMEAs and risk management, and drive CAPAs with cross-functional teams.

Fluent German and English are mandatory. This role emphasizes validation, data analysis with Minitab, and applying robust quality systems in a global

Qualifikationen

• Bachelor's degree in an engineering discipline with relevance to medical devices.
• Solid knowledge of ISO 13485, ISO 14971/24971 and MDR requirements.
• At least 3 years in medical devices or a regulated environment.

Aufgaben

• Support quality development activities for commercial production.
• Ensure compliance with quality systems and applicable standards.
• Collaborate on FMEAs and risk management documents.
• Assist with validation/re-validation of tests and processes.
• Develop and approve validation protocols and reports.
• Contribute to CAPAs and root-cause analyses.
• Support regulatory audits as quality expert.

Kenntnisse

Fluent German

Fluent English

Analytical skills

DOE knowledge

Minitab

Regulatory knowledge

Quality systems

MS Office

Multidisciplinary teamwork

Process validation

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

MS Office

Jobbeschreibung

Job Description

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

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.