Senior Quality Systems Engineer- Global Design Activities at Boston Scientific Corporation Malaysia

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Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

164500.0

Posted On

07 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Risk Management, Regulatory Compliance, Data Analysis, Project Management, Problem Solving, Collaboration, Communication, Audit Support, Process Improvement, Design Controls, Medical Device Regulations, Stakeholder Engagement, CAPA Management, Continuous Improvement, Methodologies

Industry

Medical Equipment Manufacturing

Description

Additional Location(s): N/A; Canada-ON-Mississauga; Canada-ON-Ottawa; Costa Rica-Coyol; Costa Rica-Heredia; Ireland-Clonmel; Ireland-Cork; Ireland-Galway; US-CA-Irvine; US-CA-Valencia; US-IN-Spencer; US-MA-Marlborough; US-MN-Arden Hills; 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 Senior Quality Systems Engineer serves as a Global Design Activities process owner to drive and support design activities initiatives and quality goals and priorities. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Partner with design teams across all divisions and leads global communities of practice (CoP) to drive and improve our Global Design Activities sub-processes, in collaboration with the global design activities sub-process stewards. Work mode: At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA and requires being on-site at least three days per week at a BSC location. We will also consider candidates based in other BSC sites including but not limited to Ireland, Costa Rica, and Canada. Relocation assistance: Relocation assistance is the US is available for this position at this time. Visa sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Key responsibilities will include: Demonstrated competency in implementing effective global design activities procedures to support the development of products to meet or exceed internal and external requirements. Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support) Acting on feedback trends identified through QS audit, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process. Applying advanced analytical skills by evaluating both qualitative and quantitative data including synthesizing large data sets by identifying key themes/information. Influence key stakeholders through collaborative community engagement. Help to connect the key SMEs across divisions and capitalize on networking skills to promote best practice sharing and efficient problem solving Support internal and external audits and audit responses to existing products. Monitors compliance with company policies and procedures Global CAPA ownership, particularly proven experience with complex, multi-site / multi-division problem-solving Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Ensure the development and execution of streamlined business process which help achieve VIP/Continuous Improvement goals. Required qualifications: Bachelor's degree in Science, Health, or Engineering Minimum of 5 years of Medical Device design controls and risk management experience required. Understanding of US and International regulations including 21 CFR, 820, and ISO 13485 is required, as well as the Medical Device Directive, EUMDR, and EN ISO 14971. Preferred qualifications: Strong communication (oral and written) and presentation skills. Strong project management skills Familiar with Microsoft Office Suite (Excel, PPT, Word) Requisition ID: 620000 Minimum Salary: $ 86600 Maximum Salary: $ 164500 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 Senior Quality Systems Engineer drives and supports design activities initiatives and quality goals. They partner with design teams and lead global communities of practice to improve Global Design Activities sub-processes.