Senior Supplier Quality Engineer

Danaher Corporation; Marlborough (MA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Benefits package

401(k) plan

Paid time off

Job summary

Cytiva, a Danaher operating company, is seeking a Senior Supplier Quality Engineer to strengthen the supplier quality program from Marlborough, MA / Shrewsbury, MA on-site. You will drive SCAR management, supplier audits, qualifications, and SCRs while coaching teams on robust RCA and process improvements.

You will collaborate with Engineering, Sourcing, QA and other functions to ensure compliance with ISO/CFR/GMP standards and drive continuous improvement across the supply base.

Qualifications

• Bachelor’s degree in engineering; advanced degree preferred.
• Minimum 10+ years in Quality roles, with supplier quality/audit experience.
• Expert in root cause analysis techniques and execution.
• Experience coaching stakeholders in SCARs, SCRs, audits, qualifications and transfers.
• Expert knowledge of ISO, CFR, GMP, and related standards.

Responsibilities

• Issue, monitor and approve SCARs; manage containment and corrective actions.
• Lead supplier audits and remediation activities after audits.
• Execute supplier qualifications and process qualifications; train suppliers and Cytiva staff.
• Review and manage supplier change requests (SCRs) and high-impact SCRs.
• Collaborate with cross-functional teams (Engineering, Sourcing, QA) to manage supplier quality requirements.

Education

Bachelor’s degree in engineering

Master’s degree preferred

Tools

Audit tools

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva , one of Danaher’s (https://danaher.com/our-businesses) 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. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Senior Supplier Quality Engineer is responsible for applying a continuous improvement mindset and DBS rigor to Cytiva’s supply base across the Hardware Solutions Business.

This position reports to the Supplier Quality Manager and is part of the Quality Organization l ocated in Marlborough, MA/Shrewsbury, MA and will be an on-site role.

What you will do :

• Issue, monitor and approve Supplier Corrective Action Requests (SCARs). Manage containment and correction for supplier defects and document accordingly. Able to manage quality events effectively and train others. Provide feedback and collaborative support on RCA with suppliers for all SCAR types including Critical. Coach supplier in robust RCA methodology as required.
• Experience auditor able to execute and report on supplier audits, support training/observation audits, experience in critical commodities such as CMO, sterility, aseptic technique, serum, etc. Obtain senior auditor certification and support training of provisional auditors. Able to manage annual supplier audit planning. Lead remediation activities due to failed audit.
• Execute supplier qualifications and supplier process qualifications. Able to train suppliers and Cytiva associates on methodology and process execution.
• Review, assess impact, communicate with internal stakeholders and Supplier on supplier change requests (SCRs). Able to manage complicated/high impact SCRs. Support Cytiva associates in SCR process execution.
• Collaborate with cross-functional teams (i.e. Engineering, Project Management, Sourcing, QA, etc.) on all activities required to effectively manage supplier quality requirements, supplier onboarding, and supplier monitoring

Who you are:

• Requires a minimum of a Bachelor’s degree in a technical or engineering field; a Master’s degree in a related discipline is preferred. Equivalent Quality experience in a similar business unit or industry may be considered in lieu of advanced education.
• Minimum 10+ years of experience in Quality roles, preferably in applicable supplier quality roles or similar areas with experience in managing audit programs, performance reviews and business development
• Expert in root cause analysis techniques, methodologies and execution
• Experienced in coaching internal and external stakeholders in process and techniques to execute SCARs, SCRs, audits, qualifications and work transfers
• Expert knowledge of applicable standards and regulations (e.g. ISO, CFR, GMP, etc.)

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel- roughly 25%, primarily domestic
• Must have a valid driver’s license with an acceptable driving record

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

• Pharmaceutical industry, biopharmaceutical equipment

Cytiva , 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 (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

The annual salary range OR the hourly range for this role is $110,000-$140,000 . 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 Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

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 (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

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 or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].