Danaher Corporation Quality / Compliance Engineer - ISO 13485 in Fremont, California

Danaher Company Description
Molecular Devices, LLC creates innovative, high-quality bioanalysis solutions that increase our customers’ productivity. By joining Molecular Devices, you will work with best-in-class people who share a common purpose, to be our customers' first choice for systems, consumables, software, and support that advance both basic and applied life science discovery. Our core values are critical elements of our past and future success -- The best team wins. Customers talk, we listen. Continuous improvement is our way of life. Leading edge innovation defines our future. We compete for our shareholders. Molecular Devices 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.

Molecular Devices 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.

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Description

  • Maintain product compliance of instruments and reagents by collaborating with the engineering or chemistry team
  • Review of design and development data to identify short and long-term risks
  • Recommend and execute product changes for instrumentation through design updates and engineering change orders
  • Determine process and quality improvement parameters by applying statistical methods relevant to manufacturing processes
  • Monitor, collect and present Key Performance Indicators (KPIs) related to product quality and associated quality trending information for Quality System Effectiveness Reviews
  • Management of Quality Systems as required
  • Develop compliance guidelines by researching and identifying applicable regulatory and industry compliance standards and codes
  • Develop and manage systems for components, parts and material compliance
  • Organize compliance program by preparing timetables, cost estimates, and required resources including test laboratories and equipment.
  • Attain compliance and quality by isolating and resolving non-compliance issues
  • Document compliance by recording test results and preparing and filing Declarations of Conformity

Qualification

  • Bachelor’s Degree in Engineering or related discipline required
  • Five (5) years in a Life Science, Medical Device or pharmaceutical manufacturing environment with responsibilities in product quality and compliance
  • Experience and working knowledge of ISO 9001 Quality Systems Requirements required; ISO 13485 and/or GMP/QSR experience preferred
  • 2years' experience and knowledge in Solidwork
  • A ble to develop technical documentation such as Validation Plans and Reports, SOPs, Change Control, Risk Analysis and others
  • Knowledge in the regulatory environment for laboratory instrumentation. This to include Electrical Product Safety and EMC, NRTL and CE Marking, FCC, etc.

Danaher Corporation Overview
Danaher 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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 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.

Organization: Molecular Devices
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-CA-Fremont
Schedule: Full-time
Req ID: MOL002086