Quality System Specialist - Oakville, Canada - BD

BD
BD
Verified Company
Oakville, Canada

1 week ago

Sophia Lee

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Sophia Lee

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Description

Job Description Summary:
Responsible for QMS maintenance through interactive relationship with a 3PL.


We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat.

It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.


Primary Responsibilities

  • Responsible for Quality Systems as assigned,
  • Responsible for monitoring assigned Quality System performance through established metrics and/or Quality objectives, addressing under performance and escalation with appropriate leadership when require
  • Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements, continuous process improvement and audit support.
  • Maintains awareness, follows applicable Corporate Quality procedures and may make updates to procedures, policies, training matrixes and curriculums.

Position-Specific Overview:


  • The Quality Systems Specialist will be accountable for Quality Systems as the local Subject Matter Expert (SME), providing guidance and training, facilitating meetings, escalation and ensuring compliance to the following Quality Systems as assigned:
  • Document and record control, DMS Administrator
  • Training & Curricula / C2C DLA / GMP & GDP
  • Order Fulfillment Claims support for root cause analysis and SCARs
  • Intracompany Claims
  • QMS Audits
  • Metric Data Analysis
  • Product Hold Backup
  • Maintain awareness, train and mentor distribution functions as the SME for the Quality Systems assigned as well as applicable requirements from ISO 13485 and Corporate Policies / Procedures when appropriate.
  • Participate and represent Distribution Quality on projects, implementations and initiatives associated with regional improvement goals, annual Quality objectives, integration and optimization as assigned.
  • Other duties and responsibilities as assigned.

Scope of Responsibility:


  • Ensures applicable Quality Systems comply with current ISO 13485 and corporate requirements.
  • Ensures the accurate and actionable records for the making of decisions.
  • Ensures distribution processes follows applicable released procedures.
  • Contributes to longrange Supply Chain strategies, choosing disciplines and methods appropriate to the work content and context.
  • Outputs contribute to reduced compliance risks, improved effectiveness and furthering the achievement of goals critical to company objectives.
  • Determine and pursue courses of action necessary to obtain desired results.
  • Plans and participates in disciplines strategically relevant to the business and/or functions.
  • Participates in, and may provide leadership for, multidisciplinary projects.
  • May be assigned as Site / Functional member of Quality Systems Network team for assigned Quality systems element. Sharing of best practices across local and regional sites and functions/
  • May be assigned as Site / Unit member of Quality Systems Network team for assigned Quality systems element

Requirements:


Knowledge

Skills

  • Excellent communication, problem solving, organizational and interpersonal skills are essential.
  • Selfmotivated and directed, requiring mínimal supervision
  • Demonstrated ability to work in teams to obtain results is required.
  • Effective skills in analytical thinking and problem solving required

Education/Degree

  • BS Degree required.
  • Industry Recognized certification in a Quality System Element specialty preferred.
  • Lean Six Sigma knowledge / certifications a plus.

Experience

  • A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience in Medical Device and/or Pharmaceutical regulated industry within Quality, Supply Chain and/or Distribution Center operations.


For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.

In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.


Why Join Us?


A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.

It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are eq
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