Sr Quality Systems Engineer Job

Additional Locations: (n/a)

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

Sr Quality Systems Engineer

 

About the Role:

Serve as a senior Quality representative to leading awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities.  Supports external quality audits and leads/supports internal quality audit teams to assure that site activities comply with all applicable regulatory requirements and BSC policies and procedures.

  

Responsibilities Include:

  • Responsible for maintaining internal process for continuous compliance with corporate / global quality system and external requirements.
  • Responsible for the communication and documentation of internal and external compliance-related information including changes in external requirements, corporate requirements, and local changes to ensure continuous compliance.
  • Involved in handling audit non-conformances, evaluating impact to compliance, and facilitating sustainable fixes.  
  • Providing quality and compliance input and coaching in support of product development, laboratory controls, equipment qualifications, post market product sustaining activities, quality processes, and external regulatory communications.
  • Providing support with preparation of, coordination, and management of regulatory agency and 3rd party inspection.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Providing support to departmental, functional, divisional, and corporate quality goals and priorities.
  • Reviewing and understanding essential documents such as procedures, specifications, protocols, reports, standards, CFRs, nonconformance, and CAPAs for adequacy and compliance.
  • Lead and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
  • Champions 100% compliance to Company Policy and SOPs.
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.
  • Other duties as necessary or required by the department or site.

 

Qualifications:

 

Minimum Qualifications

  • BS in Science, Health, or Engineering.
  • 5+ years of in FDA-regulated (i.e. medical device, IVD, pharma) experience.
  • Experience working to interpret and apply quality regulations and standards.
  • Adept communicating across organizational levels, serving as a company representative, and working as both a team leader and team member.

 

 Preferred Qualifications:

  • 8+ years of medical device engineering experience
  • Adept working knowledge of US and International regulations including 21 CFR 806 & 820, ISO 13485:2016, MDD, and JPAL.
  • Experience communicating with NBs and CAs.
  • Previous accreditation as quality auditor (e.g. ASQ CQA, etc)

 

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 419019

 

Company
Boston Scientific
Posted
03/27/2018
Type
Full time
Location
Marlborough, Massachusetts 01752, US