Senior Quality Systems Engineer

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
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.
   

Requisition ID: 588022

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.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.