Senior Quality Systems Engineer- Global Design Activities

bostonscientific•Valencia, MA

2d•$86,600 - $164,500•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Strong communication (oral and written) and presentation skills.
Strong project management skills
Familiar with Microsoft Office Suite (Excel, PPT, Word)

Responsibilities

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.