Senior Quality Engineer
Danaher · Chaska, MN
- Level
- Senior
- Team
- Quality
- Degree
- Required
- Experience asked
- 90+ years
- Industry
- Pharma & life sciences
- Posted
- 30+ days ago
The role in 30 seconds
A senior quality role at Danaher (pharma & life sciences) in Chaska, MN. In this role, you will have the opportunity to.
- They ask for
- 90+ years · degree required
- Tools it names
- Lean, Kaizen
Read from the posting. The full description is below.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
Your game plan for this job
Most people just hit Apply. Do these first and you show up with someone on the inside.
- 1
Find 2–3 people on the Quality team at this site
Engineers who joined in the last year or two reply most.
- 2
Send a short, curious note
Ask about the work, not for a referral. We write it for you.
- 3
Have a 15-minute chat
Good questions for this role:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
- 4
Apply, ideally with a referral
Ask if they'd refer you or introduce you to the hiring manager. Send your résumé link and tell them the day you apply.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
About the role
In this role, you will have the opportunity to
- ◆Conduct comprehensive reviews of the manufacturing SOPs (standard operating procedures), document change orders, bill of materials, service manuals, part drawings, material specification sheets, field service manuals, nonconformance records, CAPAs (corrective and preventive actions) and other quality records to ensure that they are compliant with
requirements
of the Quality System and the regulations.
- ✓Lead Kaizen events aimed at improving the transactional process, reduce process variations, and to implement lean processes in the production floor to reduce cycle time, maximize resource utilization, improve the experience and engagement of the production associates, and eliminate lean wastes such as correction, overproduction, motion, material movement, waiting, inventory, and process.
- ✓Reduce instrument defects by investing/evaluating the issues identified and implementing countermeasures to prevent recurrence.
- ✓Reduce Nonconformances by investing/evaluating the issues identified and implementing countermeasures to prevent recurrence.
- ✓Assess the risk associated with: (i). design changes; (ii). Internal product non-conformances, (iii). External post-launch issues (iv). Systemic issues of the Quality system or instrument manufacturing business.
The essential
It would be a plus if you also possess previous experience in
- ✓Certified Quality Engineering certification preferred.
Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info .
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com .
The U.S. EEO posters are available here .
For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application
Show full description ↓Show less ↑
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
Learn about the Danaher Business System which makes everything possible.
The Senior Quality Engineer for Beckman Coulter Diagnostics is responsible for ensuring the business is compliant to the Quality Management System and the Regulations.
This position is part of the Instrument Quality organization located in Chaska, MN and will be primarily on-site. You will be a part of the Instrument Quality organization and report to the Quality manager responsible for Instrument Quality.
of the job include
- •Engineering degree in a relevant field (i.e. Mechanical, Electrical, Chemical, etc.) Bachelor’s degree in field with 5+years exp. OR Master’s degree in field with 3+ years exp. OR Doctoral degree in field with 0-2 years exp
- •Experience applying Design Controls and Design Changes according to 21CFR820 to moderately complex design changes.
- •Experience applying Risk Management ISO14971 for Medical Device companies.