Quality Eng II at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Feb, 26

Salary

132000.0

Posted On

14 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality System Regulations, Medical Device Regulation, ISO 13485 Quality Standards, Microsoft Office, Collaboration, Problem Solving, Continuous Improvement, Statistical Analysis, Root Cause Investigation, Performance Improvement, Patient Safety, Product Quality, Cross-Functional Collaboration, Adverse Events Analysis, Documentation, Communication

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: This role leads technical efforts at the Arden Hills Post Market Complaint Investigation Site (CIS), focusing on analyzing product performance data to investigate and escalate issues across a range of Interventional Cardiology (IC) devices. It involves cross-functional collaboration to drive product and process improvements and enhance investigation outcomes. The position also offers high visibility across site and divisional leadership. Work Mode: At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model, requiring employees to be in our local office at five days per week. Relocation: Relocation assistance is not available for this position at this time. VISA: Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time. Your responsibilities will include: Analyze post-market surveillance data, including customer complaints and adverse events, to ensure timely identification, investigation, and resolution of safety or quality issues in compliance with regulatory and internal standards. Lead product signal escalations by conducting root cause investigations, documenting findings in the quality system, and identifying opportunities for performance improvement. May include ownership of NCEPs and CAPAs. Collaborate cross-functionally to develop and implement efficient, compliant solutions that enhance Complaint Investigation Site (CIS) processes and support organizational and regulatory goals. Communicate product performance insights through formal presentations to leadership and design teams, support published performance reports, and respond to customer inquiries directly or via the sales organization. Uphold a strong commitment to patient safety and product quality by ensuring adherence to the Quality Policy and all relevant procedures and standards. Required qualifications: 2 years of experience with a Bachelor's degree in engineering or other related technical/scientific discipline Preferred qualifications: Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards Experience in Medical Device industry or a Quality organization Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook Ability to collaborate and influence across multiple, cross-functional teams Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis Self-starter with the ability to identify improvement opportunities Requisition ID: 618312 Minimum Salary: $69500 Maximum Salary: $132000 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.

Responsibilities

Analyze post-market surveillance data to identify and resolve safety or quality issues. Lead product signal escalations and collaborate cross-functionally to enhance investigation outcomes and processes.