Quality Engineer III

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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:

This role provides focused quality engineering support within the Core Endo manufacturing core team. The position develops, establishes and maintains quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements.

The role serves as a quality representative to improve awareness, visibility and communication of quality initiatives while supporting departmental, functional, site, divisional and corporate quality goals and priorities. It also provides focused quality engineering support for operational, system and service needs supporting the Spencer RCPH — Retrievals, Catheters and Pelvic Health — organization, including Urology, PI IO&E, Endoscopy, CRM Cardiac business divisions and other Boston Scientific sites.

This is an on-site role requiring employees to work at the Boston Scientific Spencer site in alignment with business and team needs.

Your responsibilities will include:

• Provide manufacturing line support and monitor product quality.
• Identify nonconformance events and initiate, own and complete NCEP records.
• Determine and execute product and process containment activities associated with NCEP events.
• Escalate CAPAs as appropriate and own and complete assigned CAPA records.
• Determine the scope of product impact during PIR ET, PIR and field action scenarios.
• Partner with manufacturing engineers and product supervisors to provide leadership within the core team.
• Drive lean production and system processes and generate value through the VIP system, including measurable return on investment.
• Advance Protect the Core, Guardian and Delivering Excellence strategic goals, including complaint reduction, Quality Catch mitigations, workstation vulnerability score reduction, IPM improvement and preventive CAPAs.
• Partner with cross-functional core team members and share ownership of deliverables related to PCA, new products, acquisition products, DCA product support, supplier engineering and supplier quality.
• Collaborate with divisional partners in Design Quality and R&D, serving as an internal voice of the customer across Urology, PI IO&E, Endoscopy, CRM Cardiac business divisions and other Boston Scientific sites.
• Provide leadership for departmental and cross-functional engineering initiatives and serve as an effective leader or team member in supporting quality disciplines, decisions and practices.
• Provide project direction, coaching and mentoring to engineering and technical team personnel.
• Proactively investigate, identify and implement best-in-class quality engineering practices.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues, including associated risk documentation.
• Review and approve product, process and equipment qualification and validation documentation, as well as other change-control documentation.
• Generate internal quality documentation, including NCEP, CAPA, PIR ET and CAPA ET records; PTP and QSDP quality plans; and SOP, WI, GOI and KSD procedures.
• Ensure compliance with Boston Scientific requirements and applicable FDA and ISO requirements across assigned areas of responsibility.
• Identify nonconformance trends through QSIG or IPM and develop appropriate technical investigation plans.
• Investigate and analyze customer and internal complaints in support of the CIS lab.

Required qualifications:

• Bachelor’s degree in engineering or related field
• Minimum of 3 years' experience in a related role
• Experience with process validation and verification activities and risk management documentation, including design and process FMEAs.
• Knowledge of analytical techniques and statistical analysis.
• Knowledge of basic quality systems and good documentation practices.

Preferred qualifications:

• Demonstrated experience managing multiple projects across diverse engineering disciplines, including software, hardware and labeling.
• Experience in the medical device industry
• Self-starter with the ability to identify improvement opportunities.
• Experience leading cross-functional teams and driving projects to completion.
• Experience interacting with manufacturing engineering, post-market complaints, CAPA, risk management, supplier quality and process engineering functions.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint and Outlook.
• Familiarity with product and component documentation, inspection and testing, and manufacturing execution systems (MES).

Requisition ID: 633320

Minimum Salary: $ 74600

Maximum Salary: $ 141700

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—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).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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. Learn more at www.bostonscientific.com and follow us on LinkedIn.

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.