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Staff Manufacturing QA/Validat...

 
 
 

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Staff Manufacturing QA/Validation Engineer - limited for 2 years (f/m) 

BEC006653 

Summary of Role: 

Reporting to the ‘Manager Quality Control’, the ‘Senior/Staff Manufacturing QA/Validation Engineer’ will be responsible for continuous improvement of product’s quality in Munich manufacturing plant. Working closely with assembly, tech-ops and purchasing departments the role will be focused on optimization of existing processes to achieve plant’s quality and performance goals and maintain compliance.
Although office based at the Munich site the role includes travel as needed, estimated at 10 %.

Specific Responsibilities:

  • Maintain and continually improve quality processes needed to ensure compliance, effectiveness, outgoing product quality and continual improvement
  • Analyse of manufacturing trends. Recommend of improvements in manufacturing and inspection processes using pFMEA, gauge R&R SPC and other tools
  • Utilize problem solving skills to find root causes of problems that occur on assembly lines

  • Liaise with the regional and global Q&RA organisation to support the development of and ensure alignment with BEC global policies and procedures
  • Create and update of manufacturing-related quality system documents
  • Manage of process and test method validation activities related to manufacturing site
  • Create and execution of validation protocols (IQ, OQ, PQ)
  • Maintain site Master Validation Plan
  • Lead Validation Review Board meetings
  • Assist in validation activities (process, test method) at supplier sites as required
  • Liaise with Tech-ops and R&D departments on validation requirements for new and current products and processes
  • Train and support other departments in preparation of validation input documents
  • Own validation and quality manufacturing KPI’s
  • Participate in DBS events as required





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Qualifications: 


  • University/Bachelor Degree in Science, Engineering or equivalent with minimum of 5 years’ experience in a similar position
  • Deep and current knowledge of Quality Management principles
  • Solid working knowledge of Lean Six Sigma principles
  • Skilled at managing ambiguity, influencing without authority and driving for results
  • Experience of working within a global, multi-cultural, matrix organization
  • Experience of working in MedTech with solid understanding of the associated regulations
  • Fluent in English – written and verbal







 

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Our customers include hospitals, physicians' offices, diagnostic reference laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions. In fact, Beckman Coulter has more than 200,000 clinical and research instrument systems operating in laboratories around the world.

At Beckman Coulter Biomedical GmbH in Munich, located in Großhadern and Sendling, we are proud to be responsible for the worldwide research, development and manufacturing of innovative laboratory automation products. In Munich we have more than 180 associates.

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.




 

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.

You can build a career in a way no other company can duplicate. Because we are part of Danaher - a global science and technology innovator ranking #144 on the 2017 Fortune 500 list and presented with diverse team of 59,000 associates in over 30 operating companies worldwide.

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.

Come join our winning team!



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Wir freuen uns auf SIE!