Quality Engineer III, CAPA

2 weeks ago

Mississauga, Ontario, Canada Boston Scientific Gruppe Full time

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Additional Location(s): Canada-ON-Mississauga; Canada-ON-Toronto

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:
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within sustaining, operational, or system/services support.

Your responsibilities will include:

  • Work in cross-functional teams under the direction of the Quality Manager/Team Lead to support and execute processes and quality deliverables associated with CAPAs and quality systems
  • Assist with administration and management of the NCEP and CAPA process
  • Conduct NCEPs and CAPAs using systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Proactively investigate, identify, and implement best-in-class quality practices.
  • Knowledgeable on Risk Management
  • Ensure completion of assigned NCEP and CAPA deliverables per set schedules.
  • Maintain cross-functional team relationship; collaborate and facilitate effectively and positively with peers.
  • Work with manager and lead to establish and maintain goals and objectives, and ensure quality system, regulatory and safety policies and processes are followed.
  • Draft and support the development of Quality Plans and Project Tracking Plans for projects
  • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Other duties as required

Required qualifications:

  • Bachelor's Degree or higher in Engineering or science related field.
  • Minimum 3+ years of risk management/manufacturing/operations experience.
  • Experience with nonconformances, CAPA, problem solving and process improvement tools such as lean principles and six sigma
  • Must be able to communicate effectively, by analyzing, summarizing, and presenting ideas concisely via visual communication methods i.e. tables, graphs, Excel, Minitab, and PowerPoint presentation.
  • Nice to have qualifications:
  • Medical device industry experience.
  • Hands-on technical/mechanical experience and aptitude.
  • Experience with manufacturing transfer projects.
  • Ability to influence and work with a team collaboratively.
  • Demonstrated leadership of problem solving in a manufacturing support role.

Requisition ID: 584425

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 prohibited substance free workplace. Pursuant to Va. Code § , 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.

Job Segment: Lean Six Sigma, Six Sigma, Quality Engineer, Compliance, Risk Management, Management, Engineering, Legal, Finance

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