Senior Quality Engineer - Risk Specialist
Hach
Munich, Bavaria, Germany
vor 8 Std.

About UsBeckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing.

Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients.

Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs.

More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents.

For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.

Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives.

Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits.

We think you'll like what you see.If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at .

Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

Description

Reporting to the Design Quality Manager, the Sr. Quality Engineer will support new product development (laboratory automation and related software) from a QA perspective.

This person will provide guidance to the core team to organize project structure and documentation to meet design control requirements, and support design changes to already established products. Goal of the Position

  • Closely engaged in R&D projects towards introduction of new products as quality lead
  • Partner with Risk Manager and Complaint Manager to ensure compliance
  • Proactively provide guidance to maintain and improve compliance of development projects with global and local processes Specific Responsibilities
  • Ensure conformity of the design process with applicable regulation
  • Represent QA function within the core teams in charge of the development process
  • Review and Approve design and development documentation related to the products you’re in charge of
  • Develop and execute validation plans and protocols
  • Responsible for DHF completeness and maintenance
  • 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
  • Qualifications

  • Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences
  • 5 years+ experience within the regulated environment of in vitro diagnostics or medical devices
  • Fluent in English - written and verbal
  • 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
  • Development process experience or practical experience with product verification and / or product validation
  • Practical experience of workflows in laboratory environments is a plus
  • Knowledge of EN62304, ISO14971, EN62366, EN61010
  • High level of autonomy and critical thinking is required. Teamwork oriented.
  • Computer skills (MS Office products) Danaher Corporation OverviewDanaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide.
  • Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions.

    Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage.

    We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

    At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries.

    We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders.

    Come join our winning team.Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

    Organization

    Beckman Coulter - Diagnostics

    Job Function

    Quality and Regulatory Affairs

    Primary Location

    EMEA-Western Europe-Germany-Bavaria-Munich

    Full-time

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