Job Description
We are looking for a Quality Engineer (m/f/d) Medical Devices 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 a 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
Location
CHE Wangs - Straubstrasse
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.
