Senior Supplier Quality Engineer

• 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. 

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.

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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 [email protected].