Siemens Careers

Dir,Design Quality Assays

Tarrytown, New York
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Diagnostics
Requisition Number: 240353
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Master's Degree
Travel Required: 10%

Job Description:

Director Design Quality Assays

 

Position Overview
An expert providing technical leadership, knowledge and experience by overseeing control system development and design controls in new assay product development. The incumbent works with R&D and Manufacturing to create a control system ensuring that our products meet customer, regulatory and manufacturing requirements over the life of the product. Ensure that assay PDP teams meet the intent of regulations, standards and internal procedures to achieve compliance. The function has significant strategic impact on the overall success of the LD business.  Will lead compliance improvement culture change in R&D.

 
Responsibilities
  • Create, implement and assure sustainability of best practices in new assay control system development and compliance to Design Control regulations.

  • Directs complex technical activities and provides recommendations regarding assay design choices.

  • Directs the development and monitoring of quality metrics for Design Quality.

  • Resolves extremely complex problems across multiple departments, functions and sites.

  • Provides training in Design Control and control system development to relevant LD staff.

  • Successfully defines work flows, jobs and reporting relationships to obtain optimum effectiveness.

     
    Specific qualifications required:
  • Expertise in reagent product development for diagnostic products. PhD or MS degree in the sciences and 15+ years of experience. Experienced and knowledgeable in Design Control regulations.

  • Experienced in techniques driving to root cause.

  • Sound knowledge of data analysis with detailed understanding of precision and bias analyses.

  • Ability to understand complex issues and translate into operable experiments and solutions leading to robust linkages between optimizations, design spaces and control system specifications.

  • Ability to work independently and in project teams.
  • Excellent communication skills (written and spoken)



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



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