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 located 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.
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.
