Quality Engineer III - IC HCP Training / CQA at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Feb, 26

Salary

144400.0

Posted On

13 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Medical Device Standards, Regulations, Clinical Trials, Collaboration, Critical Thinking, Data Analysis, Process Improvement, Documentation, Training, Compliance, Risk Identification, Communication, Organization, Influencing, Problem Solving

Industry

Medical Equipment Manufacturing

Description

Additional Location(s): US-MN-Maple Grove 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 Quality Engineer III - IC HCP Training / CQA will support the quality framework that governs Health Care Professional (HCP) training for the WATCHMAN (WM) and VITALYST portfolios. This role also provides Clinical Quality Assurance (CQA) support to ICTx and WM clinical teams across pre-market and post-market studies. This global, highly visible role partners closely with Medical Education and Clinical Trial teams to implement BSC's objectives efficiently and compliantly—upholding medical device standards, regulations, and quality system requirements. You'll influence strategy across Clinical, Design Assurance, and Medical Education. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove office three days per week. Relocation assistance may be available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position. Your Responsiblities Will Include: Support CQA and HCP training, assisting teams through BSC's Quality System by providing support for interpreting regulations and translating them into practical, compliant processes. Assist in representing ICTx and WM HCP Training interests in the Global HCP Training Community of Practice (CoP). Contribute to discussions and help implement improvements that enhance compliance, effectiveness, and efficiency of HCP training processes. Support the execution of the HCP QA Assessment Schedule by coordinating logistics, preparing documentation, and assisting HCP QA staff by providing guidance during assessments and follow-up. Participates in quality escalations discussions with global, cross-functional partners. Support NCEPs, CAPAs, and SCARs, and assist in implementing corrective and preventive actions as needed. Contribute to the maintenance and improvement of global quality systems by supporting implementation efforts, gathering feedback, and sharing insights across products and divisions to promote best practices in HCP training in both commercial and clinical settings. Support regulatory inspection readiness by helping prepare documentation, coordinating inspection activities, and partnering with clinical teams and CQA peers to ensure audit readiness for WM and ICTx studies. Promote data-driven compliance by collecting and analyzing quality metrics, identifying potential risks, and supporting process improvement initiatives that reinforce a strong culture of quality. Quality system responsibilities Demonstrate an unwavering commitment to patient safety and product quality by adhering to the Quality Policy and all documented processes and procedures. Ensure the right resources (people, tools, and systems) are available to sustain Quality System compliance and adherence to the BSC Quality Policy. Foster a work environment that models and reinforces the Quality Policy and Quality System. What we're looking for Required qualifications Bachelor's degree in Science, Health, Engineering, or a related field. 3+ years experience in medical device, pharma, or a similarly regulated industry. Exceptional organization and the ability to influence without authority at all levels. Strong presentation and communication skills. Proven collaboration and critical-thinking skills. Preferred qualifications Working knowledge of U.S. and international regulations and standards applicable to BSC. Experience in Medical Education and/or Clinical Quality Assurance. Familiarity with BSC IT systems (e.g., eCAPA, Windchill, APPROVE). Experience partnering with cross-functional teams such as Regulatory, R&D, Clinical, Medical, Sales Training, and Quality. Requisition ID: 618002 Minimum Salary: $ 76000 Maximum Salary: $ 144400 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 III will support the quality framework for HCP training and provide Clinical Quality Assurance support to clinical teams. This role involves collaborating with various teams to ensure compliance with medical device standards and regulations.