Quality Engineer II

Boston Scientific•Alpharetta, GA

13h•Onsite

About The Position

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. As a Quality Engineer II, you will provide advanced quality engineering support across manufacturing, systems and services, and materials functions. You will apply strong technical expertise to develop, optimize and sustain quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements. In this role, you will operate with greater independence, lead key quality initiatives and serve as a trusted quality representative across the Urology, Oncology and Endo-Surgery business units and other supported areas. You will leverage data-driven decision-making, statistical analysis and structured problem-solving to improve product and process reliability, drive continuous improvement and ensure compliance. This position plays a critical role in identifying risks, influencing cross-functional teams and advancing a proactive quality culture aligned with business objectives.

Requirements

Bachelor’s degree in engineering or a related technical field
Minimum of 2 years' experience in quality, manufacturing or engineering roles
Demonstrated knowledge of quality engineering principles, statistical analysis and problem-solving methodologies
Experience applying reliability engineering concepts and tools, including DOE and statistical process control
Ability to analyze complex data sets, interpret results and communicate insights effectively
Strong organizational skills and attention to detail with the ability to manage multiple priorities
Ability to work independently and collaborate cross-functionally in a fast-paced environment

Nice To Haves

Experience supporting medical device or other regulated industry environments
Working knowledge of FDA, ISO or other regulatory standards
Experience with quality systems, nonconformance investigation and corrective and preventive actions (CAPA)
Certification or experience with continuous improvement methodologies such as Lean or Six Sigma

Responsibilities

Lead and execute technical reliability studies and evaluations, including design of experiments (DOE)
Recommend and implement design and test methods, including statistical process control procedures, to achieve product reliability targets
Analyze performance reports and process control statistics to identify variables impacting products and processes and drive improvements
Ensure corrective and preventive actions meet established reliability and quality standards and are effectively implemented
Develop, implement and sustain reliability engineering programs aligned with company, customer and regulatory requirements
Create and apply mathematical models to identify units, batches or processes with elevated failure risk
Propose and influence design or process changes to improve system and product reliability
Utilize advanced statistical analysis and structured problem-solving methodologies to evaluate process capability and product acceptance
Identify, prioritize and resolve complex quality issues using systematic problem-solving approaches
Lead or contribute to product review boards and drive investigations into nonconformance trends and customer or internal complaints
Support and lead continuous improvement initiatives across supported business units
Ensure compliance with ISO 14001 and Boston Scientific Environmental, Health and Safety standards