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

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

164500.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

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

Industry

Medical Equipment Manufacturing

Description

Recruiter: Spencer Gregory Hale Senior Quality Systems Engineer- Global Design Controls About the role: 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. 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: 617149 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. 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. 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 role involves serving as a process owner for Global Design Activities, driving design initiatives and quality goals. Responsibilities include implementing design procedures, partnering with process owners, and supporting audits and compliance.