Senior Supplier Quality Engineer

About the role

Hologic is seeking a Senior Supplier Quality Engineer to support the Global Supplier Quality organization. This role ensures that suppliers consistently meet stringent quality and regulatory requirements.

Responsibilities

• Assess and qualify suppliers, oversee their manufacturing and quality practices
• Resolve supplier nonconformances
• Lead data-driven improvements using tools like PPAP, SPC, GR&R, and CAPA
• Partner with R&D, Design Assurance, Post-Market, Manufacturing, and global suppliers to protect product quality, reliability, and patient safety

Requirements

• Strong working knowledge of medical device and IVD regulations, including cGMP21 CFR 820 (QSR), ISO 13485, ISO 14971, ISO 9001, MDR/IVDR, and other global regulations (e.g., FDA, Canada, Brazil, Japan)
• Deep familiarity with supplier quality management practices, including qualification, performance monitoring, and escalation
• Understanding of PPAP (Production Part Approval Process) concepts and requirements (desirable)
• Knowledge of validation (IQ, OQ, PQ), risk management, and CAPA processes as they relate to suppliers
• Strong grasp of metrology, measurement systems analysis (MSA, including GR&R), and quality records requirements

Skills

• Ability to execute and maintain supplier quality processes in accordance with the Quality Management System and regulatory standards
• Skilled in conducting technical reviews of suppliers to assess their capability to manufacture materials/components to specification
• Experience overseeing and monitoring suppliers for: Manufacturing and process controls, Quality control practices, Corrective actions and continuous improvement, First Article Inspection (FAI)
• Experience defining, approving, and following up on PPAP requirements for new and revised purchased parts
• Proficient in issuing and managing SCARs, SACAs, and NCEs in systems like Agile, and tracking workflow timing against KPIs
• Strong problem-solving skills, including use of SPC, statistical sampling, root cause analysis, and CAPA to prevent repeat failures
• Experience working cross-functionally with Post Market Surveillance, Quality Engineering, Manufacturing Engineering, R&D, and other teams to address supplier-related complaints and issues
• Capable of managing day-to-day supplier nonconformities (containment, disposition, returns, rework, sorting, sample management)
• High proficiency with Microsoft Office for reports, data analysis, and presentation of supplier performance metrics
• Experience with ERP systems and updating supplier status and approvals for materials
• Knowledge of project management techniques and ability to handle multiple complex projects concurrently
• ISO 13485 Lead Auditor capability is a strong plus

Behaviors

• Strong, clear communicator—effective in written and verbal communication with internal stakeholders and suppliers at all levels
• Analytical and objective, able to evaluate data and translate it into meaningful proposals, action plans, and improvements
• Highly organized, able to manage multiple suppliers, projects, and issues simultaneously
• Collaborative and solution-oriented, building constructive relationships with global suppliers and internal teams
• Self-driven and able to work both independently and as part of cross-functional teams
• Quality-focused, consistently applying risk-based thinking and regulatory requirements to supplier decisions

Qualifications

• Bachelor’s degree in Engineering (e.g., Plastics, Mechanical, Electrical, Mechatronics, or other relevant discipline)
• ASQ Supplier Quality Engineer certification is a plus
• Minimum 5 years of professional experience with a Bachelor’s degree in roles with similar responsibility, decision-making, and problem solving
• Recognized expertise in supplier quality or a closely related function within a regulated or manufacturing organization
• Experience in a medical device or IVD environment strongly preferred
• Experience supporting internal and external audits as a Subject Matter Expert for supplier quality; willingness to travel domestically and internationally for supplier visits and audits

Pay

The annualized base salary range for this role is $98,500-$154,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.