Senior Quality Engineer - Cardiac Diagnostics (CDx)

Boston Scientific; Arden Hills (MN); On-site; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Senior Quality Engineer to provide critical quality support for Cardiac Diagnostics. The role leads CAPA activities, problem solving, and cross-functional collaboration to improve device quality, processes, and compliance.

The candidate will interact with product development, supplier, and production teams, champion risk management and verification activities, and mentor teams in quality discipline adoption.

Qualifications

• Bachelor’s degree in engineering or related discipline.
• 5 or more years of relevant quality engineering experience (3 or years with a relevant master's degree).
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.
• CAPA experience including leading root cause investigations, implementation of corrective actions and verification of effectiveness
• Familiar with medical device risk management activities and their connection to organizational processes
• Familiar with quality tools and problem-solving techniques

Responsibilities

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Act as an effective leader and team member in supporting quality disciplines, decisions, and practices.
• With input from organizational stake holders organize, schedule, and conduct investigational and problem resolution meetings with cross-functional team members to coordinate, contribute to and document NCEP/CAPA processes including determinations, activity tracking, and record closures.
• Evaluate the adequacy and compliance of systems and practices against regulations and company documentation.
• Participate in team decision making and display team problem solving/communication skills.
• Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
• Collaborate with technicians and engineers in dispositioning non-conforming material, assisting in identification of manufacturing process defects, identification of primary root causes, and understanding corrective and preventative actions.
• May be responsible for working with process owners, suppliers, and other internal groups
• Advise, review and approve process validation and verification activities that support corrective actions.
• Collect and analyze process defect data for product/process improvement efforts (e.g., nonconforming product, failure analysis, customer complaints, etc.)
• Support NCEP/CAPA activities as Subject Mater Expert, mentor, and trainer.
• Support regulatory submissions to notified bodies.

Skills

Quality engineering

CAPA

Root cause analysis

Problem solving

Regulatory awareness

Education

Bachelor’s degree in engineering or related discipline

Master’s degree in related field (advantage)

Tools

Windchill

MS Office

Job description

Recruiter: Spencer Gregory HaleSenior Quality Engineer - Boston Scientific Cardiac Diagnostics (CDx)About this role:We are seeking a Senior Quality Engineer to provide critical quality engineering support to the Boston Scientific Cardiac Diagnostics’ business ensuring the highest quality results to improve the business’ products, services, and processes. The role will lead quality initiatives centered on continuous improvement and organizational compliance while partnering closely with cross-functional product development, supplier, and production teams to lead the organization’s Corrective and Preventive Actions (CAPA) process.In a fast-paced, high growth and dynamic environment, this position will be key in supporting the engineering, production and commercial teams achieve their business unit goals. The ideal candidate will be comfortable interfacing with multi-disciplined teams at all levels to provide quality leadership, facilitate complex problem solving, and drive effective solutions for impactful and highly visibility issues.Your responsibilities will include:Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Act as an effective leader and team member in supporting quality disciplines, decisions, and practices.With input from organizational stake holders organize, schedule, and conduct investigational and problem resolution meetings with cross-functional team members to coordinate, contribute to and document NCEP/CAPA processes including determinations, activity tracking, and record closures.Evaluate the adequacy and compliance of systems and practices against regulations and company documentation.Participate in team decision making and display team problem solving/communication skills.Proactively investigate, identify, and implement best-in-class Quality Engineering practices.Collaborate with technicians and engineers in dispositioning non-conforming material, assisting in identification of manufacturing process defects, identification of primary root causes, and understanding corrective and preventative actions. May be responsible for working with process owners, suppliers, and other internal groupsAdvise, review and approve process validation and verification activities that support corrective actions.Collect and analyze process defect data for product/process improvement efforts (e.g., nonconforming product, failure analysis, customer complaints, etc.)Support NCEP/CAPA activities as Subject Mater Expert, mentor, and trainer.Support regulatory submissions to notified bodies.Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.What we’re looking for in you:Required QualificationsBachelor’s degree in engineering or related discipline5 or more years of relevant quality engineering experience (3 or years with a relevant master's degree).Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.CAPA experience including leading root cause investigations, implementation of corrective actions and verification of effectivenessFamiliar with medical device risk management activities and their connection to organizational processesFamiliar with quality tools and problem-solving techniquesExperience in Medical Device industryPreferred qualifications:Prior interactions with the following disciplines: software and hardware development, manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineeringExperience working with MS Office applications and PLM (Windchill)2+ years’ experience in Validation, Statistical sampling and/or Root Cause InvestigationFamiliar with QMS documentation including but not limited to DHF, DMR, DHR, SOPs, WIs, FMEAs and other Quality recordsProblem Solving Certification (CQE, Six Sigma, etc.)Demonstrated program/project management skillsCritical thinker and active listener with good time management skillsSelf-starter with the ability to quickly learn about new processesExcellent analytical and communication skills (written and oral)Requisition ID: 634779Minimum Salary: $ 85000Maximum Salary: $ 161500The 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 identity, 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.