Senior Quality Assurance Engineer (Defined Term)

Senior Quality Assurance Engineer

Boston Scientific has been named one of Forbes' World's Best Employers and one of America's Best Employers for Engineers, reflecting our commitment to innovation, collaboration, and engineering excellence.

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.

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.

Your responsibilities will include:

• 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.

Qualifications:

Required qualifications:

• 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.

Preferred qualifications:

• 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.

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) 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).

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.

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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.