Senior Quality Engineer - 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 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.
• 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 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
• Experience in Medical Device industry

Preferred qualifications

• Prior interactions with the following disciplines: software and hardware development, manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering
• Experience working with MS Office applications and PLM (Windchill)
• 2+ years' experience in Validation, Statistical sampling and/or Root Cause Investigation
• Familiar with QMS documentation including but not limited to DHF, DMR, DHR, SOPs, WIs, FMEAs and other Quality records
• Problem Solving Certification (CQE, Six Sigma, etc.)
• Demonstrated program/project management skills
• Critical thinker and active listener with good time management skills
• Self-starter with the ability to quickly learn about new processes
• Excellent analytical and communication skills (written and oral)