Engineer, Senior Quality Systems

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 Sr. Quality Systems Engineer serves as a Quality Team representative to improve the awareness, visibility and communication of quality assurance initiatives that support assigned departmental, functional and site quality goals and priorities. This role will champion elements of the Boston Scientific Quality System such as Management Review, Nonconformance Management, Audit Readiness and Readiness Review along with other Quality Assurance projects. The incumbent will develop, establish, and maintain quality-engineering methodologies, systems, and practices to meet Boston Scientific, customer and regulatory requirements and provide quality engineering support within technical development concepts, regulations, operational services and systems.
 
Your responsibilities will include:

• Providing technical support and leadership within the Quality Assurance and Quality Systems organization to support the Quality Policy and Quality System
• Providing guidance for maintaining compliance to regulatory and corporate requirements as an advocate for a preventive quality culture
• Leading and mentoring in assurance implementation, process controls and CAPA systems designed to meet or exceed internal and external requirements 
• Utilizing systematic problem-solving methodologies to identify, communicate, prioritize and resolve quality-related issues 
• Gathering and analyzing 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 
• Executing and leading the Internal audit program for the site according to the defined scope and regulation and supporting external audit readiness
• Leading quality inspectors, technicians and documentation associates as necessary
• Performing other duties as assigned 

 
Required Qualifications:

• Bachelor’s degree in Biomedical Engineering or related engineering discipline
• Minimum of 5yrs of technical experience in the medical device or pharmaceutical industry
• Minimum of 2yrs of experience with internal auditing and corrective and preventive action (CAPA) 
• Experience with 21 CFR Part 820 and ISO 13485
• Experience working in cross-functional teams and driving projects to completion
• Ability to understand and evaluate procedural documents to ensure compliance in all applicable regulations and requirements
• Customer service-oriented with ability to communicate effectively (written and verbally) with individuals on all levels 

 
Preferred Qualifications:

• ASQ Certified Quality Engineer (CQE) or Biomedical Auditor (CBA)
• Project management experience with strong presentation and facilitation skills
• Working knowledge of analytical techniques and statistical analysis
• Proficient with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent)
• Ability to work independently and collaborate with cross-functional teams to complete projects 
• Strong interpersonal skills, with ability to communicate effectively with individuals on all levels
• Strong critical thinking and analytical skills: process and results-oriented
• Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively
   

Requisition ID: 558413

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 drug-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.