Senior Supplier Quality Engineer

Danaher Corporation•Marlborough, MA

3d•$110,000 - $140,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Previous experience in Pharmaceutical industry, biopharmaceutical equipment

Responsibilities

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.
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.