Senior Quality Engineer - Cardiac Diagnostics (CDx)

Socket.dev; Arden Hills (MN); On-site; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific Corporation seeks a Senior Quality Engineer to provide critical quality engineering support for Cardiac Diagnostics. You will lead CAPAs, drive continuous improvement, and collaborate with cross‑functional teams to ensure regulatory compliance and patient safety.

The role involves problem solving, validation activities, and data-driven improvement of processes and products. Strong QA background in medical devices is required.

Qualifications

• Bachelor’s degree in engineering or related discipline.
• 5+ years of quality engineering experience (3+ years with a related master’s degree).
• Knowledge of Quality System Regulations, Medical Device Regulation, and ISO 13485.
• CAPA experience including leading root cause investigations and verification of effectiveness.
• Familiar with medical device risk management activities and related processes.
• Experience in Medical Device industry.

Responsibilities

• Apply systematic problem-solving methodologies to identify and resolve quality issues.
• Lead quality disciplines and participate in CAPA decisions.
• Organize and conduct investigational meetings with cross-functional teams and document CAPA activities.
• Evaluate adequacy and compliance of systems against regulations and documentation.
• Collaborate with technicians and engineers to disposition nonconforming material and identify root causes.
• Review and approve process validation and verification activities supporting corrective actions.
• Collect and analyze defect data for product/process improvements.

Skills

CAPA leadership

Problem solving

Analytical skills

Communication skills

Time management

Education

Bachelor’s degree in engineering

Master’s degree preferred

Tools

Windchill

MS Office

PLM

Job description

Recruiter: Spencer Gregory Hale

Senior 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 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
• Experienceworking with MS Office applications andPLM (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)

Requisition ID:634779

Minimum Salary:$85000

Maximum Salary: $161500

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

Among other requirements, Boston Scientific maintains specificprohibited substantest 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.