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Engineer, Sr Quality Systems

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Quincy, MA, US, 62301

 

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.

 

The Sr. Quality Systems Engineer serves as a Quality Team representative who will improve the awareness, visibility and communication of quality assurance initiatives that support assigned departmental, functional, site, divisional and corporate quality goals and priorities. The incumbent will develop, establish and maintain quality-engineering methodologies, systems, and practices to meet BSC, customer and regulatory requirements and provide quality engineering support within technical development concepts, regulations, operational services and systems.

 

In this role you will…

  • Provide project direction using quality disciplines, decisions, and practices; coach and mentor the engineering and technical teams as appropriate; mentor teams on applying Corrections and Corrective actions (CAPA); advocate a preventive quality culture
  • Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Apply technical quality engineering principles to assigned projects, products and sites to guide them into implementation
  • Apply effective and systematic problem-solving methodologies to identify, communicate, prioritize and resolve 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.  
  • Identify and implement best quality engineering practices as requested by management
  • Develop and execute streamlined business systems to identify and resolve quality issues effectively
  • Identify and implement effective processes and design control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external regulations and quality standards 
  • Perform internal audits according to defined scope and regulation; ensure external audit readiness
  • Perform other duties as assigned 

 

Required Qualifications

  • Bachelor’s degree in engineering; life science or technology discipline 
  • Minimum 5 years of experience in medical device field or healthcare industry
  • Minimum 2yrs experience with auditing and corrective and preventive action (CAPA) 
  • Experience with manufacturing process controls and/or distribution
  • Experience with 21 CFR Part 820, ISO 13485, AIMDD, MDD, MHLW, MDR SOR/98-282, 21 CFR Part 211, ISO 14971, Therapeutic Goods Regulations 2002, Resolution RDC No 16 or March 28, 2013, 21 CFR Part 4
  • Ability to understand and evaluate procedural documents to ensure compliance in all applicable regulations and requirements
  • Strong organizational skills with ability to multi-task and prioritize competing responsibilities in a fast-paced environment 
  • Customer service-oriented with ability to communicate effectively (written and verbally) with individuals on all levels 
  • Ability to work independently and collaborate with internal teams - leadership skills are essential
  • Strong problem-solving and critical thinking skills; analytical, process and results-oriented

 

Preferred Qualifications

  • ASQ certification
  • Experience with warehouse management and/or supply chain distribution
  • Project management experience 

 

Requisition ID: 543569

 

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.


Nearest Major Market: Macomb

Job Segment: Senior Quality Engineer, Medical Device Engineer, Supply Chain, Compliance, QA, Engineering, Operations, Legal, Quality

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