Quality Engineer ensuring automotive production meets quality standards. Resolving quality claims and driving improvements in quality KPIs across manufacturing operations in Inđija, Serbia.
About the role
- Design Quality Assurance Engineer for Beckman Coulter Diagnostics ensuring compliance in design processes and engaging in R&D projects for new product introductions. Responsible for documentation review and risk management activities in Munich.
Responsibilities
- Closely engage in R&D projects towards introduction of new products or design changes as quality representative
- Proactively provide guidance to maintain and improve compliance of development projects with global and local processes
- Ensure conformity of the design process with applicable regulation
- Review and approve design and development documentation
- Develop and execute validation plans and protocols
- Generate and maintain the risk management files
- Drive risk assessments
- Contribute to risk management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics
- Support post-market surveillance activities
Requirements
- Degree in chemistry, life sciences, engineering or quality management or equivalent education gained through work experiences
- Work experience or research experience in chemistry, life sciences, engineering or quality management (+2 years)
- Fluent in English - written and verbal. German is a plus.
- Computer skills (MS Office products)
- Practical experience of workflows in laboratory environments
- Experience within the regulated environment of in vitro diagnostics or medical devices
- Experience in design verification and/or validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment
Benefits
- Health insurance
- Flexible working arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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