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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.
Requirements: Bachelors degree in a technical field.
7+ years of relevant experience in Quality Design, Operations, or Service
Excellent written and verbal communication skills, with the ability to work with partners across the company
Working knowledge of IEC13485,60601,62353 and 21CFR820 regulations
Proven success mentoring and influencing across cross-functional, global environments.
Hands-on experience with CAPA and structured problem solving
Ability to travel internationally up to 10%
This position is open to all candidates.