Senior Quality Assurance Engineer (Defined Term)

bostonscientific•Quincy, MA

4d•Hybrid

About The Position

This is a defined-term position with a duration of two years. The Senior Quality Assurance Engineer will utilize quality engineering methodologies, systems, and practices to meet Boston Scientific, customer, and regulatory requirements within the Quincy site distribution supply chain environment. This role serves as a quality representative to improve awareness, visibility, and communication of quality initiatives in support of departmental, functional, site, divisional, and corporate quality goals. The role provides focused quality engineering support for new product launches, general site distribution operations (inbound and outbound), and systems or services support within the Quincy distribution network from a quality perspective. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Requirements

Bachelor’s degree in engineering or an equivalent combination of education and experience.
Minimum of 5 years’ experience and up to 7 years’ experience in quality engineering within the medical device industry, including distribution or supply chain environments.
Experience with supply chain distribution practices.
Strong communication and cross-functional collaboration skills.
Experience with Lean, Six Sigma, process improvement, root cause analysis, and structured problem-solving methodologies.
Excellent interpersonal and relationship-building skills.
Ability to travel up to 5 percent.

Nice To Haves

Experience with SAP ERP and Manhattan systems.
Exposure to packaging and final pack requirements.
Proven ability to influence without direct authority.
Supplier quality experience.
Strong attention to detail.

Responsibilities

Provide leadership by championing departmental and cross-functional engineering initiatives.
Provide project direction, coaching, and mentoring for engineering and technical team members.
Serve as a technical mentor for identifying and resolving quality issues, including nonconforming events and CAPA processing.
Identify and implement effective process controls and systems to support the development, qualification, and ongoing distribution of products that meet or exceed internal and external requirements.
Proactively investigate, identify, and implement best-in-class quality engineering practices.
Lead the implementation of quality assurances, process controls, and CAPA systems to meet or exceed regulatory and customer requirements.
Review, evaluate, and approve SOPs, work instructions, project plans, risk management files, and process verifications, as applicable.
Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Assure the development and execution of streamlined business systems that effectively identify and resolve quality issues.
Collaborate cross-functionally with site operational teams and divisional partners to ensure quality compliance on assigned projects.
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.
Engage in continuous process improvement and optimization initiatives.