Senior Supplier Quality Engineer

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   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   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