Staff Quality Assurance-Supplier Quality Engineer

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Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Beckman Coulter Diagnostics one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 laboratorys 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 makingwe 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 Staff Quality Assurance-Supplier Quality Engineer is responsible for serving as the single Quality member for supplier transitions and design changes related to cost savings initiatives that directly influence product cost reliability and supply continuity. This role drives measurable organizational impact by ensuring new suppliers components and product improvements are qualified verified and integrated into manufacturing on time within scope and without downstream quality issues. This position reports to the Sr. Supplier Quality Manager and is part of the Supplier Quality located in Chaska MN and will be an on-site role.

Remote option will be considered for qualified candidates who are not local.

In this role you will have the opportunity to:

• Serve as the single Quality lead for Value Analysis/Value Engineering (VAVE) programs from our North America sites including instrument system costreduction initiatives EOLdriven design changes supplierinitiated changes and qualitybased product improvementsensuring full quality oversight from concept through manufacturing integration and measured by ontime delivery to project milestones costsavings realization and factbased Quality approvals enabling smooth manufacturing integration.
• Own Quality accountability for supplier selection approval and component qualification collaborating crossfunctionally with Strategic Sourcing Procurement R&D and Operations to assess supplier capability qualify new components and ensure rigorous Purchasing Controls are applied throughout the change process.
• Act as primary Quality authority for all design and supplier modifications ensuring projects comply with ISO 13485 and all applicable Beckman Coulter quality system requirements; drive quality decisions and approvals for advancement at each project phase.
• Ensure that costreduction design evolution and supplier transition activities fully meet Purchasing Controls Design Controls Document Controls and Risk Management expectations with owning final Quality approval for readiness to advance and indicated by absence of postimplementation quality issues.
• Create maintain and approve required quality documentationincluding risk analyses supplier qualification records change control documentation and support files measured by clear auditready documentation supporting seamless transfer of updated components or designs into manufacturing.

The essential requirements of the job include:

• Bachelors degree in technical field with 14 years experience or Masters degree in field with 12 years experience or comparable
• Minimum 7-10 years experience in quality engineering or supplier quality within manufacturing environments.
• Strong knowledge of quality systems risk management CAPA and statistical methods.
• Excellent communication skills and ability to influence both suppliers and internal stakeholders.
• Willingness to travel up to 15%

It would be a plus if you also possess previous experience in:

• Experience in FDA-regulated or medical device manufacturing environments.
• Certifications such as CQE CQA Six Sigma or equivalent.
• Demonstrated ability to evaluate and qualify supplier or design changes that impact performance cost manufacturability or compliance.

Beckman Coulter Diagnostics a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $140000 to $160000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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