Boston Scientific Senior Quality Systems Engineer 

United States, Illinois, Quincy 

811618905

The Senior Quality Systems Engineer develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provide quality engineering support within technical development concepts, regulatory, operational, or system/services support.

Your responsibilities will include:

• Applies technical quality engineering principles to assigned processes or projects and guides them into implementation.
• Identifies and implements effective process control systems to support the on-going distribution of products to meet or exceed internal and external quality and regulatory requirements.
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Analyze Quality data for management reporting (CAPA Review Board, Quality Management Review), and advise management on potential improvements or enhancement to quality systems and processes in the company.
• Plan and conduct scheduled quality system audits to assess compliance with FDA regulations, ISO standards, MDD, and internal requirements. To include audit scheduling, investigation, evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions.
• Ensure External Audit Readiness.
• Coach and mentor teams on applying Corrections and Corrective actions. Supports team members by setting an example and providing feedback/guidance on Root Cause Analysis (Ex: Investigation, Risk Assessment, Solution, VOE)
• Assess site compliance to new or revised Global processes.

Required qualifications:

• Bachelor’s degree or higher in engineering, life science, technology or related discipline.
• 5+ years of experience within the healthcare industry investigating processes and writing scientifically justified conclusions linked to true root cause (CAPA Process).
• Experience as Lead Auditor for at least one (1) internal audit.
• Ability to travel up to 25%.
  

Preferred qualifications:

• Completed an external Lead Auditor Training/Certification Program (Ex: ASQ or ComplyGuru ISO 13485:2016 Certified Lead Auditor Training).
• Exchanges complex information with others, potentially guiding and persuading others.
• Regularly participates in discussions and presentations in small, cross-functional meetings, logically presenting information to convey key messages.
• Experience with Supply Chain and/or Distribution processes.
• Advocate for Preventive Quality and Value Improvement Process culture.
  

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

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.