Quality Engineer I at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

110500.0

Posted On

19 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality System Regulations, Medical Device Regulation, ISO 13485 Quality Standards, Microsoft Office, Analytical Techniques, Problem Solving, Continuous Improvement, Statistical Analysis, Collaboration, Mentoring, Technical Guidance, Product Performance, Patient Safety, Quality Policy, Cross-Functional Teams, Investigative Equipment

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 this role: This Quality Engineer I role offers an employee the opportunity to be part of the Electrophysiology Complaint Investigation Site within the Post Market Quality Assurance team at Boston Scientific. This role will be supporting our Capital Equipment products by completing investigations and approvals. The primary activity for this role is to support analysis of investigations into field complaint allegations against Boston Scientific products within the electrophysiology division. This position is a vital part of improving patient care by ensuring Boston Scientific device allegations are investigated efficiently and effectively, to drive actions to improve current & future product performance. Your responsibilities will include: Analyzing customer complaints, events, and other post market surveillance data by examining the data for patterns and trends and investigating when necessary. Conducting product signal escalation analysis, investigation, and quality system documentation to identify performance improvement opportunities. May include NCEP & CAPA ownership. Mentoring product investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques. Grow team utilization of investigative equipment (X-Ray, FTIR, SEM, etc.) Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes are effectively implemented while still meeting organizational and regulatory requirements. Communicating product performance through formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization. Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations. Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Communicating emerging product quality issues to Senior Engineers and/or Management for awareness to cross functional areas including Research and Development, Supplier Quality and Manufacturing Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Required Qualifications: Bachelor's degree in engineering or other related technical/scientific discipline Preferred Qualifications: Bachelor's degree in Electrical Engineering 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: 618469 Minimum Salary: $ 58200 Maximum Salary: $ 110500 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 Quality Engineer I role involves analyzing customer complaints and conducting investigations to improve product performance. This position is crucial for ensuring efficient and effective investigations into product allegations to enhance patient care.