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Engineer II, 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

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 This Role:
The Quality Systems Engineer II will utilize quality-engineering methodologies, systems, and practices which meet BSC, customer and regulatory requirements. The incumbent will serve as a Quality Team representative to improve awareness and visibility, and communicate quality assurance initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities.  
 
In this role you will:

  • Champion Quality System elements such as Management Review, Audit Readiness, Readiness Review and Other Quality Assurance projects
  • Develop and maintain a comprehensive understanding of the regulations and standards listed in the BSC Global Policy Quality System - interpret and apply the following standards: 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, as applicable to our site
  • Serve as Quality Assurance representation on project teams by providing guidance for maintaining compliance to regulatory and corporate requirements 
  • Ensure site is Verified Accredited wholesale distributor (VAWD) compliant; maintain relations with VAWD to prepare for bi-annual VAWD audit 
  • Implement quality assurance tools internally and externally to improve control, address gaps to manufacturing and distribution processes, and to eliminate non-essential activities
  • Lead and manage projects associated with site quality initiatives to ensure the distribution center’s interests are accurately and objectively represented
  • Lead and support continuous improvement projects as well as CAPA and LEAN initiatives 
  • Lead functional teams in developing solutions for quality-related issues and identify opportunities for continuous improvement 
  • Provide technical support and leadership within the Quality Assurance and Quality Systems teams
  • Review and approve CRs, PCAF, DCAF changes to new and existing processes
  • Revise standard operating procedures, perform investigations of drug material through review of customer processing records and licenses database in SAP
  • Serve as a technical resource within the facility for review, approval and resolution of non-conformities
  • Support the site Drug Pedigree program, maintain State Level Licensing for all states that require license to distribution prescription medical device or prescription drugs
  • Perform other duties as required, including VIP

 

Required Qualifications

  • Bachelor’s degree in engineering or life science discipline 
  • Experience with auditing and corrective and preventive action (CAPA) 
  • 2 years of experience in medical device field or healthcare industry
  • 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
  • Customer service-oriented with ability to communicate effectively (written and verbally) with individuals on all levels 
  • Strong problem-solving and critical thinking skills; analytical, process and results-oriented
  • Ability to work independently and collaborate with internal teams - leadership skills are essential
  • Strong organizational skills with ability to multi-task and prioritize competing responsibilities in a fast-paced environment 

 

Preferred Qualifications

  • ASQ certification
  • Experience with supply chain distribution, Drug & Device Licensing experience
  • Experience with NABP Drug Distribution Accreditation

 

 

Requisition ID: 534994

 

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

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