Senior Supplier Quality Engineer

Jobtailor; Shrewsbury (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Cytiva in the United States is seeking an experienced Supplier Quality leader to drive Danaher Business System rigor across the hardware solutions supply base and oversee the SCAR process. You will guide containment, corrective actions, and cross-functional collaboration to uphold high quality standards.

Responsibilities include leading supplier audits, coaching in root-cause analysis, and ensuring compliance with ISO, CFR, and GMP.

Qualifications

• Bachelor’s degree in a technical or engineering field is required.
• Master's degree preferred.
• Minimum 10+ years in Quality roles, preferably supplier quality.
• Experience with audit programs and root-cause analysis.
• Knowledge of ISO, CFR, GMP standards.
• Willingness to travel ~25% domestically.

Responsibilities

• Issue, monitor and approve SCARs.
• Manage containment and correction for supplier defects.
• Lead supplier audits and remediation activities.
• Coach suppliers in robust root-cause analysis.
• Collaborate with Engineering, Sourcing, QA and cross-functional teams.
• Report to the Supplier Quality Manager.

Skills

Root Cause Analysis

Supplier Quality Management

Audit Program Management

ISO CFR GMP Standards

SCARs SCRs Management

Supplier Audits

Change Request Assessment

Coaching

Education

Bachelor's degree in technical field

Master's degree preferred

Job description

Apply a continuous improvement mindset and Danaher Business System rigor to Cytiva's supply base across the Hardware Solutions Business
Issue, monitor and approve Supplier Corrective Action Requests (SCARs)
Manage containment and correction for supplier defects and document accordingly
Manage quality events and train others
Provide feedback and collaborative support on root-cause analysis with suppliers for all SCAR types, including Critical
Coach suppliers in robust root-cause analysis methodology
Execute and report on supplier audits
Support training and observation audits
Obtain senior auditor certification and support training of provisional auditors
Manage annual supplier audit planning
Lead remediation activities due to failed audits
Execute supplier qualifications and supplier process qualifications
Train suppliers and Cytiva associates on methodology and process execution
Review supplier change requests (SCRs), assess impact, and communicate with internal stakeholders and suppliers
Manage complicated or high-impact SCRs
Support Cytiva associates in SCR process execution
Collaborate with Engineering, Project Management, Sourcing, QA and other cross-functional teams on supplier quality requirements, onboarding and monitoring
Report to the Supplier Quality Manager within the Quality Organization

Requirements

• Minimum Bachelor's degree in a technical or engineering field
• 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
• Experience managing audit programs, performance reviews and business development
• Expert in root cause analysis techniques, methodologies and execution
• Experience coaching internal and external stakeholders in processes and techniques for SCARs, SCRs, audits, qualifications and work transfers
• Expert knowledge of applicable standards and regulations, including ISO, CFR and GMP
• Ability to travel roughly 25%, primarily domestic
• Must have a valid driver's license with an acceptable driving record
• Preferred experience in the pharmaceutical industry and biopharmaceutical equipment
• Master's degree in a related discipline is preferred

Core Competencies

Demonstrates expertise in Supplier Quality Management, including root cause analysis, audit execution, and supplier training. Proficient in applying quality standards such as ISO, CFR, and GMP within the pharmaceutical and biopharmaceutical sectors.

Highest-signal resume keywords

• Root Cause Analysis
• Supplier Quality Management
• Audit Program Management
• ISO, CFR, GMP Standards
• Supplier Corrective Action Requests (SCARs)

ATS Optimization Keywords

Hard Skills

• Root Cause Analysis Techniques
• Supplier Audits
• Supplier Qualifications
• Quality Event Management
• Change Request Assessment

Soft Skills

• Coaching
• Collaboration
• Training

Certifications & Qualifications

• Senior Auditor Certification

Industry Keywords

• Pharmaceutical Industry
• Biopharmaceutical Equipment
• Quality Assurance (QA)
• Continuous Improvement
• Danaher Business System