Senior Quality Engineer - Capital Equipment Service at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Apr, 26

Salary

0.0

Posted On

05 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Service Quality, Risk Management, Continuous Improvement, Product Reliability, Mentorship, Collaboration, Root-Cause Analysis, Quality Systems, Medical Device Standards, Data Analysis, Project Management, Technical Guidance, Regulatory Compliance, Field Service, Design Controls, CAPA

Industry

Medical Equipment Manufacturing

Description

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's 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, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About the role: The Senior Service Quality Engineer is a subject-matter expert in service quality for Boston Scientific's Medical Electrical Equipment/ Capital Equipment (CE) products. This position provides leadership in developing, executing, and continuously improving product related service quality requirements, ensuring that service and installation processes meet global regulatory requirements and deliver exceptional customer outcomes. The role bridges product design and field service, ensuring that service performance and feedback directly inform product improvement, risk management, and reliability engineering. The Service Quality Engineer operates with minimal supervision, leads cross-functional initiatives, mentors peers, and influences the strategic direction of service quality within the organization. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include: Lead integration of service requirements into new-product design and risk-management processes. Serve as the service-quality owner for assigned products, ensuring alignment between DHF, DMR, and field-service documentation. Evaluate complex product or process changes for quality and risk impact; ensure all risk controls remain effective. Champion continuous improvement of product reliability through analysis of field performance data, and service metrics. Establish robust systems to ensure accurate Service History Record capture and traceability via Service Management and SAP systems. Represent service quality in design reviews, risk assessments, and post-market monitoring. Process Focus Drive enhancement and standardization of CE-related Service Quality System elements: Design Controls, Risk Management, CAPA/NCEP, Installation & Servicing Controls. Lead significant CAPA/NCEP investigations, ensuring strong root-cause analysis and sustainable corrective actions. Partner with global and regional teams to implement best practices for service quality metrics and reliability measurement. Lead Service quality-system integration for acquisitions, assessing gaps, developing integration plans, and mentoring local quality teams. Monitor key process indicators for CE service performance, influencing operational and business decisions. Collaborate with upstream engineering to implement systemic improvements that reduce service-related nonconformances. People & Culture Focus Serve as a role model of BSC's quality and compliance culture. Provide mentorship and technical guidance to junior team members and cross-functional partners. Influence leadership teams by presenting balanced risk-based rationales that protect patients while enabling business agility. Foster collaboration across Service Development Engineering, Service QA, NPE Project Management, Field Service, and Global teams. Promote a culture of curiosity, accountability, and high performance. Lead VIPs and continuous-improvement initiatives that drive measurable efficiency gains. Encourage a “Yes - and here's how” mindset to support business enablement while maintaining compliance. Required qualifications: Bachelor's degree in a technical field Minimum of 6 years of related work experience including relevant experience in the Medical Device industry Working knowledge of relevant standards and regulations such as 21CFR820, IEC60601, IEC 62353, ISO 13485. Preferred qualifications: Masters degree in engineering Experience working with medical electrical equipment ASQ Certification in Six-Sigma Green Belt and/or Quality disciplines Experience working with BSC Quality System Requisition ID: 618064 The anticipated annualized base amount or range for this full time position will be $ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs. For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Responsibilities

The Senior Service Quality Engineer leads the integration of service requirements into new-product design and risk-management processes while ensuring alignment between documentation. They champion continuous improvement of product reliability through analysis of field performance data and service metrics.