Principal Quality Systems Engineer at Boston Scientific Corporation Malaysia

Alpharetta, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Mar, 26

Salary

188300.0

Posted On

06 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, CAPA, Audit Readiness, Continuous Improvement, QSR, cGMP, ISO 13485, EU MDR, Cross-Functional Collaboration, Quality Metrics, Data Analysis, Problem-Solving, Leadership, Mentoring, eQMS Tools, Compliance

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: We are seeking a strategic and experienced Principal Quality Systems Engineer to join our Quality team at the Johns Creek site. In this key role, you will serve as the subject matter expert (SME) on the Corrective and Preventive Action (CAPA) system, leading initiatives that enhance our quality systems and ensure compliance with global regulatory requirements. You'll partner cross-functionally to promote a culture of continuous improvement, audit readiness, and quality accountability—driving Boston Scientific's mission of transforming lives through innovative medical solutions. Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office in John's Creek, GA. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include: Act as the SME for the CAPA system, managing and mentoring on CAPA and nonconformance processes. Lead preparation for and participation in external audits (e.g., FDA, ISO, MDSAP), including coaching staff on audit readiness best practices. Serve as a quality representative to increase awareness, visibility, and communication on quality initiatives across departments. Provide quality systems support to ensure compliance with Boston Scientific's Quality System requirements and assess system effectiveness. Benchmark and implement best practices tailored to business needs while aligning with regulatory requirements and operational goals. Serve as a recognized leader in QSR, cGMP, ISO, and EU MDR standards; collaborate with the QA Director on critical quality decisions. Lead and support internal audits; identify opportunities for advancing the Quality Systems at the Johns Creek site. Monitor and report on quality metrics that drive continuous improvement and customer satisfaction. Champion cross-functional collaboration to align teams on quality and compliance goals. Cultivate a culture of accountability, customer focus, and ownership of quality responsibilities. Provide coaching and guidance to engineering and technical teams to strengthen quality capabilities. Apply structured problem-solving methodologies to address quality issues and communicate resolutions effectively. Track action items, report site metrics, and lead Management Review and CAPA Review Board meetings. Monitor progress against quality plans and escalate risks to leadership when necessary. Advise leadership on strategic quality system improvements that support long-term business objectives. Qualifications: Required qualifications: Minimum of 10+ years experience in a Medical Device, Pharmaceutical or related field including a minimum of 5 years' experience in quality systems, quality engineering, or related function in the medical device industry. Demonstrated expertise in QSR, cGMP, ISO 13485, and EU MDR standards. Experience leading cross-functional teams and complex compliance projects. Ability to travel up to 10% for audits and cross-site initiatives. Preferred Qualifications: Advanced degree (e.g., MS, MBA, MEM) Lead Auditor Certification ISO 13485:2016, ASQ CQA or CQM/OE. Proven ability to influence without authority and mentor others in quality disciplines. Prior experience with eQMS tools (e.g., TrackWise, Agile, MasterControl). Previous experience mentoring or leading others in quality system practices. Experience with quality metrics and data analysis to drive improvement. Prior experience with eQMS tools (e.g., SmartSolve, Windchill, MasterControl) and SAP. Previous experience mentoring or leading others in quality system practices. Experience with quality metrics and data analysis to drive improvement. Requisition ID: 617253 Minimum Salary: $ 99100 Maximum Salary: $ 188300 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). 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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. 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 test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Responsibilities

The Principal Quality Systems Engineer will act as the subject matter expert on the CAPA system, leading initiatives to enhance quality systems and ensure compliance with global regulatory requirements. Responsibilities include preparing for external audits, providing quality systems support, and driving a culture of accountability and continuous improvement.