Quality Engineer (m/w/d) – Validation, FMEA & Regulatory Compliance, Medical Devices

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.

Job Description About the Role Are you a quality-driven engineering professional with a passion for precision, compliance, and making medical technology safer? We are looking for a

Quality Engineer (m/w/d)

to join our multidisciplinary team in

Wangs, Switzerland

, supporting validation, risk management, and quality assurance activities within a highly regulated medical device manufacturing environment.

This role sits at the intersection of engineering rigour and regulatory compliance — ideal for professionals with hands-on experience in

process validation (IQ/OQ/PQ)

,

risk management (FMEA, ISO 14971)

, and

quality systems (ISO 13485, EU MDR)

.

We also welcome applications from professionals with backgrounds in

Sterilization Validation

and

Quality & Regulatory Affairs

.

What You Will Do Quality & Compliance

Support all quality development activities for commercial production

Ensure compliance with internal procedures,

FDA regulations

, and applicable international standards (ISO 13485, EU MDR, ASTM)

Serve as quality subject matter expert during regulatory and internal audits

Validation & Process Qualification

Support validation and re-validation of test methods and manufacturing processes

Develop, review, and approve

protocols and reports

for test method validation

Implement

IQ, OQ and PQ

process qualification activities, including protocol and report review

Risk Management

Cross-functionally collaborate with Manufacturing Engineering on

FMEAs

(design, production, user)

Create, maintain, and approve

risk management documents

in line with

ISO 14971 / 24971

Continuous Improvement & Problem Solving

Lead and support

CAPA

processes: root cause analysis, problem-solving methodologies, and corrective/preventive action implementation

Perform

statistical analyses

to determine process capability indicators using tools such as

Minitab

and

DOE (Design of Experiments)

Support the Manufacturing Engineering team across all quality-related tasks

What You Bring Education

Bachelor's degree in an engineering discipline (preferably Mechanical, Process, Materials Science, Chemical, or Pharmaceutical Engineering)

Experience & Knowledge

Experience in the

medical device industry

or a comparable regulated environment

Practical knowledge of global MedTech standards:

ISO 13485, ISO 14971/24971, EU MDR

Hands‑on experience with validation activities (IQ/OQ/PQ) , statistical tools and CAPA processes

Skills

Fluent in German and English

— both written and spoken (mandatory)

Strong analytical and problem‑solving skills

High level of accuracy and process‑oriented working style

Proficient in

MS Office

(especially Word)

Knowledge of

DOE

and

Minitab

statistical software

Collaborative mindset — comfortable working in multidisciplinary, international teams

Why Join Us

Work in a

state‑of‑the‑art

MedTech environment

in Switzerland

Be part of a cross‑functional team where your quality expertise drives real patient impact

Grow within a culture that values precision, accountability, and continuous improvement

Engage with international standards and global regulatory frameworks on a daily basis

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.

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)

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information 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