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 Bachelors degree in a technical or engineering field; a Masters 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 drivers license with an acceptable driving record

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

• Pharmaceutical industry biopharmaceutical equipment
  

Cytivaa 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 atDanaher Benefits Info.

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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