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Senior Quality Engineer-Packaging and Labeling Job

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Date: Sep 17, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MN-Minnetonka; US-MN-Arden Hills; US-MN-Maple Grove


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.


Sr. Packaging and Labeling Design Quality Engineer 


About the role:

A Packaging and Labeling Design Quality Engineer serves as a point person for project teams, working with stakeholders to gather requirements and provide support for Packaging and Labeling projects, with focus on problem resolution, issue correction and prevention, change assessment rigor and continuous improvement. 


Your responsibilities include:
: Serve as a Subject Matter Expert on established Packaging and Labeling processes and guidelines. Mentor and guide teams through Packaging and Labeling procedures and policies, with a view to improving overall in-house processes and awareness of key standards/principles. Accountable for Packaging and Labeling design and process knowledge for assigned projects.
Problem Solving & Continuous Improvement: Lead the resolution of Packaging and Labeling issues related to non-conformance reports, CAPAs, customer complaints and regulatory actions using established problem-solving methodologies. Facilitate within cross functional team to identify improvement opportunities, lead improvement initiatives, troubleshoots to resolve roadblocks, serve as a sounding board for problem resolution/prevention and ensures smooth, continuous progress on projects. Provide appropriate level of leadership and coaching to ensure participation and buy in from stakeholders in order to sustain improved process.
Stakeholder Management: Communicate improvement initiatives and results regularly to Quality team and upper management. Ensure participation and buy in from stakeholders on improvement opportunities, trends and issues.
Product Support: Facilitate Packaging and Labeling change implementation. Ensure rigor in change assessment and review, with a strong focus on ownership and quality. Work closely with cross functional teams to ensure improvement gains are sustained on a long term basis.

What we’re looking for in you:
Minimum Qualifications

  • BS in Engineering, Packaging Science or other relevant field 
  • Minimum of 5 years of Medical Device Quality and/or Packaging and Labeling engineering experience preferred
  • Travel less than 5% of the time
  • Understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485 and EN ISO 1 4971.


Preferred Qualifications

  • Experience in Problem Solving Methodologies such as Ishikawa Diagram
  • Corrective and Preventive (CAPA) mindset 
  • Strong communication and presentation skills
  • Excellent attention to detail
  • Good project management skills 
  • Effective critical thinking skills to evaluate variety of alternatives and their impact to product and business
  • Competent with use of Microsoft Office Suite



Requisition ID: 489974


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.


Nearest Major Market: Boston

Job Segment: Package Design, Quality Engineer, Medical, Engineer, Manufacturing, Engineering, Quality, Healthcare