Senior Staff Quality Assurance Engineer in Miami, FL

$150K - $200K(Ladders Estimates)

Danaher   •  

Miami, FL 33299

Industry: Manufacturing & Automotive

  •  

8 - 10 years

Posted 27 days ago

About Us


Beckman 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 www.beckmancoulter.com.

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


The Sr. Staff Quality Assurance Engineer supports new product development (instruments, reagents, consumables, and software) from a QA perspective. The primary role of the position is to provide guidance and direction to cross functional core teams to organize project structure and documentation to meet design control requirements in support of market release of new products. The position also supports post-launch design changes to established products.


RESPONSIBILITIES:

  • Provide strategic direction for new product development and design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality and risk management.
  • Ensure proactive compliance to all applicable internal, domestic and international regulations including: US 21 CFR 820 (QSR), ISO 14971:2017 and ISO 13485:2016.
  • Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management and document controls.
  • Lead extended Quality teams for new product development and design change projects.
  • Review and approve design and development documentation including: Design Development plans, Design Change plans, User Needs, Design Input and Design Output documents, Design Verification Protocols and Reports, Design Validation Protocols and Reports, Software Requirement documents and associated Software Verification test procedures and reports, and System Risk Assessment documentation.
  • May review and approve engineering drawings, specifications, procedures, engineering changes, manufacturing work instructions, etc.
  • Assures that newly developed products are successfully transferred into the supply chain including manufacturing and service environments.
  • Participates in Design Reviews and develop, approve and review associated documentation.
  • Responsible for Design History File (DHF) completeness and maintenance.
  • Utilize problem solving techniques ad take a broad perspective to identify innovative solutions.
  • Interact frequently with other functional areas and operating entities which requires specialized depth and/or breadth of expertise


Valid Through: 2019-10-15