January 25, 2024 Full TimeZug Switzerland
Senior Quality Engineer Risk Management
Job Overview
The Risk Leader is responsible for reviewing risk management-related topics within Design and Development Projects and participates in the development, implementation, and administration of SHL’s risk management processes. This is a Switzerland – based role that will work across the global organization and collaborate with stakeholders. The Senior Quality Engineer (Risk Management) will be expected to identify risks and drive mitigations in the multiple business processes, such as the design and development of medical device products, internal and external manufacturing process developments, transportation, and storage activities.
Main Responsibilities
Identify risks and possible errors in the process and systems from possible sources
Lead and execute risk management activities for manufacturing processes in development
Lead and execute risk management activities for manufacturing sites in development
Lead and execute risk management activities related to product development — from inception through manufacturing, product launch and scale-ups
Work with suppliers on the identification and mitigation of risks
Support creation of Design Verifications, Process and Design Validations plans/reports, as well as development activities
Guides teams on the risk-based approach to product and process developments
Take actions to reduce or eliminate risks in product and process design and create resulting Control plans
Ensure RMF is compliant to regulatory requirements (21 CFR Part 820, ISO 13485, and ISO 14971)
Maintain and continuously improve the Risk Management process
Support internal and external regulatory audits and inspections.
Minimum qualifications
Minimum 7 years of experience in the medical device industry
Experience in manufacturing processes development and qualification/validation (molding, automation, metal forming)
In-depth knowledge of medical device risk management according to ISO 14971 standard, and experience (3+ years)
Fluency in English
Working experience with 21 CFR Part 820, ISO 13485
Preferred qualifications
In-depth knowledge of 21 CFR Part 820, ISO 13485, GHTF Guidance, including Risk-Based approaches and Process Validation.
In-depth knowledge of techniques, tools and methodologies such as PHA, FMEA, FTA.
Experience in application of quality and six sigma methods such as Ishikawa, 5Why, DMAIC, DoE.
A solution-oriented growth mindset coupled with decision-making skills.
Strong writing and verbal communication skills.
Business travel required to max 25%.
Medium fluency in German
Skills & Qualification
Master degree in engineering field.
Medium fluency in German
Experience in applied statistics
Knowledge of Design for Manufacturing and Assembly method
Knowledge of Total Productive Maintenance, Reliability Centered Maintenance methods
We Offer
A company culture with Focus on Customer, Operate with Ethics and Integrity, Drive Simplicity, Learn and Improve, & Deliver Together
Modern working environment with state-of-the-art facilities and technologies
Challenging assignments in a fast-growing and innovative industry
Position in a dynamic, international team of highly skilled professionals
Various opportunities for personal and professional development within a global organization
Flexible hours and hybrid working policy
Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at RecruitCH@shl-group.com.
Please note: We do not consider applications from recruitment agencies for this position.
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