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Boston Scientific · 1 day ago

Senior Quality Systems Engineer- Global Design Activities

Marlborough, MA

Full-time

Hybrid

Mid, Senior Level

$87K/yr - $164K/yr

5+ years exp

Boston Scientific is a leader in medical science, dedicated to solving significant health industry challenges. The Senior Quality Systems Engineer will serve as a process owner for Global Design Activities, focusing on quality engineering methodologies and ensuring compliance with regulatory requirements while collaborating with design teams across divisions.

Health CareMedicalMedical Device

No H1B

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

Qualification

Medical Device design controlsRisk management experienceUSInternational regulationsQuality engineering methodologiesProject management skillsMicrosoft Office SuiteCommunication skillsPresentation skills

Required

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