Quality Engineer - Medical Devices (Full/Part time)

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 the makers of possible.

BD is one of the largest global medical technology companies in the world. Advancing the world of healt 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.

Why Join Us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

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 2-3 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

Click on apply if this sounds like you!

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.

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