Quality Engineer

Recruiter: Spencer Gregory Hale

About the role:  

The Quality Engineer I will collaborate with Quality Management to recommend, design, and implement functional process improvements across the Braiding & Molding Technology manufacturing floor.  Will work to develop, establish, and maintain Quality methodologies, systems, and practices which meet Boston Scientific, customer, and regulatory requirements. The Quality Engineer I will perform Quality investigations and serve as a Quality representative for Data Analytics and Quality Metric reporting. Will provide partnership with cross-functional teams to deliver project support needed to integrate new product development.

Your responsibilities will include: 

• Identify Manufacturing signals (OOS and scrap) by dispositioning non-conforming material, assisting in identification of primary root causes, and understanding corrective and preventative actions
• Lead investigations to determine products affected by Non-Conformance issues, Hold Notices (Quality Notifications), Product Inquiry Reports, and Field Action data
• Quality support on value stream and quality process improvement projects
• Identify, support, and lead quality projects to support production unit area strategy
• Ensure Regulatory compliance in day-to-day responsibility by utilizing quality tools and processes (PFMEA, risk reduction, process change analysis)
• Support Preventive Quality initiatives in value stream; drive & participate in Workstation Vulnerability Assessments program to support the Production Area Strategy
• Provide training and guidance to the Quality Technicians on internal policies and procedures
• Ensure that corrective and preventive measures meet acceptable reliability standards
• Gain understanding of Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans
• Support the evaluation of the adequacy and compliance of systems, operations, and practices against regulation and company documentation
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• May be responsible for audit preparation and audit activities

Required qualifications:

• Bachelor of Science degree in engineering, technology, science, or related field
• Ability to collaborate and influence across multiple, cross-functional teams
• Strong ability to successfully multi-task with adaptability
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook

Preferred qualifications:

• Bachelor of Science degree in engineering/technology field
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards
• Experience in Medical Device industry
• Experience on an automated/high-volume line
• Comfort speaking to groups of individuals including divisional senior leaders; presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences
• Demonstrated effective change leadership and results-oriented focus
• Demonstrated problem-solving & data analysis capabilities

Requisition ID: 600608 

Minimum Salary: $ 58200 

Maximum Salary: $ 110500 

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 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 identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.