Quality Assurance Engineer IV

4w4 weeks ago

Hologic, Inc.

Alajuela, CR · Full-time · $35,000 – $50,000

About this role

This role is responsible for managing the Nonconformance and Corrective Action (NCE) program, including overseeing the lifecycle of divisional nonconformances, publishing status reports, and hosting Material Review Board (MRB) meetings. The position ensures consistent application of NCE processes across sites and manufacturing partners while supporting escalation and investigation of significant nonconformances impacting product quality or regulatory compliance.

Day-to-day activities include mentoring NCE owners in investigation, documentation, root cause analysis, resolution, and escalation of nonconformities. The engineer also supports the development and maintenance of manufacturing transition procedures, acting as a subject matter expert for design transfer activities to ensure effective product transfer from development into manufacturing.

This role establishes and maintains quality oversight processes for internal contract manufacturing sites, monitoring production performance metrics, nonconformances, CAPAs, complaints, and audit findings. It coordinates issue resolution and corrective actions impacting product compliance and serves as a liaison between the divisional quality assurance team and Supplier Quality Engineering for external contract manufacturers and OEMs.

Supervisory responsibilities include interviewing, hiring, training, and developing employees, as well as planning, assigning, and directing work. The position offers the opportunity to influence cross-functional teams and drive changes within a regulated medical device environment, ensuring alignment with QMSR and ISO 13485 requirements.

Requirements

Strong knowledge of design transfer, process validation, and change control within regulated industries
Analytical skills for data-driven decision making and process monitoring
Excellent written, verbal, and presentation skills
Demonstrates independent decision making and prioritization, including independent resolution of conflicts
Effective cross-functional collaboration and communication skills with ability to influence across functions and drive changes
8 plus years’ experience preferably in medical device industry
Experienced with FDA Quality System Regulations, ISO 13485, MDSAP, Medical Device Directive and Medical Device Regulation
English level B2+ and Spanish Advanced

Responsibilities

Manage the NCE program including nonconformances lifecycle, status reports, and MRB meetings
Ensure consistent application of NCE processes across sites and manufacturing partners
Support escalation and investigation of significant nonconformances impacting product quality or regulatory compliance
Mentor NCE owners in investigation, documentation, root cause analysis, resolution, and escalation of nonconformities
Support development and maintenance of manufacturing transition procedures including design transfer, change control, and monitoring
Act as SME for design transfer activities, ensuring effective transfer of product from development into manufacturing
Establish and maintain quality oversight processes for internal contract manufacturing sites, monitoring performance metrics and coordinating issue resolution
Serve as liaison between divisional quality assurance and Supplier Quality Engineering for external contract manufacturers and OEMs