Senior Supplier Quality Engineer

Are you passionate about driving supplier excellence and ensuring compliance in a fast-paced, global environment? Hologic is seeking a Senior Supplier Quality Engineer to support our Global Supplier Quality organization, ensuring that components, materials, and services from suppliers consistently meet stringent quality and regulatory requirements.

In this role, you'll assess and qualify suppliers, oversee their manufacturing and quality practices, resolve supplier nonconformances, and lead data‑driven improvements using tools like PPAP, SPC, GR&R, and CAPA. You'll partner closely with R&D, Design Assurance, Post‑Market, Manufacturing, and global suppliers to protect product quality, reliability, and patient safety. If you enjoy technical problem solving, supplier collaboration, and being a key gatekeeper for incoming quality in a regulated environment, this role is for you.

Knowledge

* Strong working knowledge of medical device and IVD regulations, including:

* cGMP

* 21 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)

* Ability to define, approve, and follow 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.

Experience

* 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…