Senior Quality Engineer Risk Management
vor 3 Wochen
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 13485Preferred 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 GermanSkills & 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 methodsWe 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-
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