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Sr. Staff Quality Assurance Engineer in San Jose, California at Beckman Coulter Life Sciences

Date Posted: 4/13/2019

Job Snapshot

Job Description

Job ID: BEC014354

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

Beckman Coulter is looking for a dynamic individual to lead our quality and regulatory efforts to support and drive initiates that provide support to quality system activities within our Life Sciences business. The incumbent ensures compliance to quality standards and provides direction to ensure regulatory strategies are supported. Works with site management to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.
 
The incumbent provides leadership to support and guides site-wide quality system oversight efforts including:

• Drives and maintains effectiveness of the post market customer feedback
• Provides oversight for internal audit and calibration processes
• Provides training for quality systems and regulatory areas
• Leads and drives action from quality system metrics
• Establishes operational objectives and assignments
• Oversees Risk Management process
• Hosting ISO and customer audits
• Develop systems to ensure we maintain compliance to all ISO, and Quality Policies of Beckman Coulter
• Accountability for the effectiveness and facilitation of the CAPA Review Board
• Provides oversight of design controls for new product development

Job Requirements



Qualifications

• BS degree in engineering or science degree, MS preferred
• 10 years’ experience in a regulated (FDA, ISO, & GMP) environment
• Risk Management skills – preferred
• Diagnostics and medical device experience - preferred
• Strong analytical skills
• Proven track record in quality system implementations
• Effective leadership, interpersonal skills, and teamwork skills
• Effectively communicates to ensure positive outcomes
• Hands-on experience in statistical analysis
• Self-starter


Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.