Danaher Corporation Staff Quality Assurance Engineer in Loveland, Colorado
Danaher Company Description
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 atwww.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 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.
* Ensure conformity of the design process with applicable regulations and company procedures.
* Represent all QA functions involved with the project within the core team structure. Support and engage with extended QA team on a regular basis to ensure on time delivery of activities.
* Review and approve design and development documentation related to the products supported.
* Contribute to risk management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics.
* 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. * Communicate difficult concepts and negotiate with others to adopt a different point of view. * Interpret internal or external business challenges and recommend best practices to improve products, processes or services.
* Support corrective action activities resulting from customer complaints and coordinate resolutions with appropriate functions.
* May develop and/or support quality assurance tests to ensure product specifications are met.
* May review and approve engineering drawings, specifications, procedures, engineering changes, manufacturing work instructions, etc.
* May lead audit and inspection preparation, resolution of audit and inspection findings.
* May review, investigate, resolve and report on quality discrepancies. * May manage process and product non-conformances in line with company procedures.
- Bachelor degree in engineering or science discipline with nine years of experience in a regulated environment or Master’s degree in engineering or science discipline with seven years of experience in a regulated environment.
- Experience in application of design controls in accordance with 21 CFR Part 820, ISO 13485, and ISO 9001 for the development of products and design changes.
- High level of autonomy and critical thinking is required. Teamwork oriented.
- Must be able to multi-task and prioritize in a fast-paced environment.
- Must have strong verbal and written communication skills and be capable of producing detailed and comprehensive quality system documentation and reports.
- Computer skills (MS Office products).
- ASQ Certified Quality Engineer (CQE) is a plus.
- Ability to travel up to 10%
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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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: Beckman Coulter - Diagnostics
Job Function: Engineering
Primary Location: North America-North America-United States-CO-Loveland
Req ID: BEC012897