Principal Service Quality Engineer

At our company, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.

The Principal Service Quality Engineer provides technical leadership and advanced expertise to ensure our capital equipment products meet the highest standards of quality, safety, and reliability. This role serves as a subject matter expert (SME) for service quality engineering within the laser portfolio, influencing service processes, product design for serviceability, and supporting field reliability improvements.
Key Responsibilities

Provide technical leadership and oversight for service quality throughout the product lifecycle from design and development through post-market support.
Partner with Service Development Engineering to ensure serviceability, maintainability, and reliability are incorporated into product design requirements.
Lead development and review of Service Risk Analyses, Service Plans, installation/maintenance validation activities, and field service documentation.
Ensure service controls and field procedures are compliant with global regulatory requirements (e.g., 21 CFR 820.170, ISO 13485, ISO 14971).
Represent Service Quality in cross-functional reviews, risk assessments, and change control activities impacting field service or customer use.
Drive root cause analysis and CAPA activities related to service issues, ensuring effective and timely closure.
Collaborate with divisional Quality and Post-Market Surveillance teams to ensure service-related data feeds into product reliability models and quality planning. Support trend analysis of field performance data to identify systemic issues, product reliability risks, and improvement opportunities.
Participate in internal and external audits as a Service Quality SME; provide audit readiness support to divisional teams.
Support process maturity initiatives by developing and refining tools, templates, and metrics used across the Service Quality function.
Build strong partnerships with R&D, Manufacturing, and Field Service organizations to influence design and serviceability outcomes.
Provide mentorship and technical guidance to Service Quality Engineers across Service Quality team.
Partner with Service Development Engineering leadership and Quality Management to ensure consistent support and prioritization of service projects across the portfolio.