Principal Service Quality Engineer at Boston Scientific Corporation Malaysia

, , Israel -

Full Time

Start Date

Immediate

Expiry Date

10 Mar, 26

Salary

0.0

Posted On

10 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Service Quality, Technical Leadership, Risk Analysis, Regulatory Compliance, Root Cause Analysis, CAPA, Trend Analysis, Mentorship, Collaboration, Problem Solving, Service Development, Quality Management, Field Service, Product Reliability, Post-Market Support, Service Plans

Industry

Medical Equipment Manufacturing

Description

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. Bachelor's 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%

Responsibilities

Provide technical leadership and oversight for service quality throughout the product lifecycle, ensuring serviceability, maintainability, and reliability are incorporated into product design. Collaborate with various teams to drive root cause analysis and support process maturity initiatives.