Job Description 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
Qualifications
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
Salary Range CHF95,600.00 - CHF145,775.00 CHF Annual
Equal Opportunity Employer Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
#J-18808-Ljbffr