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Quality Assurance Manager in Richmond Hill, Ontario at Nobel Biocare

Date Posted: 1/28/2019

Job Snapshot

Job Description

Job ID: NOB002855

About Us

Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.


Description

Currently in pursuit of a career Quality Assurance? Then apply at Nobel Biocare - a world leader in the field of dental implants.


Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements. 


We are currently seeking a self-motivated and extremely organized Quality Assurance Manager to join our Quality department.


If you are interested in joining our World Class North American Quality Team, please apply for the opportunity TODAY!


As a Quality Assurance Manager, you will be responsible for providing Quality and Regulatory support for the Canadian (Primary) and North America market covering the Nobel Biocare Ontario facility with a focus on quality and regulatory training onsite, hosting regulatory audits, ensuring processes and procedures are in place and effective (develop as needed) for the Nobel Biocare Richmond Hill facility.


RESPONSIBILITIES:

  • Provides regulatory, quality assurance, analysis, audit counsel, environment and training support, covering all medical device regulatory standards (Primary) Health Canada SOR-98-282, MDSAP, CFR 21-820, ISO 13485-2016, to the Ontario organization. 
  • Analyzes regulatory aspects of operations activity and recommends actions that maximize efficiencies and compliance while ensuring high product quality and ensuring the highest level of customer service. 
  • Audits hosting from all regulatory or notified bodies is a strong element of this position and ensuring Facility readiness for such audits.

Job Requirements



Qualifications

REQUIREMENTS:

  • Bachelor of Science with an emphasis in Engineering, Biomedical or in related field preferred; Master’s in Quality Systems preferred
  • 7+ years’ experience in a similar medical device role with an emphasis in Quality compliance QA/RA
  • Thorough knowledge ISO 13485, MDR Requirements, FDA's QSR Regulations
  • Perform internal training of QSR Regulations and ISO Standards
  • Intermediate experience in Microsoft Word, Excel, Access Trackwise and R/3; SAP preferred
  • Working Knowledge of Health Canada SOR-98-282, ISO 13485, MDR Requirements, FDA's QSR Regulations CFR 21-820, MDSAP and General regulatory requirements

PREFERRED SKILLS/EXPERIENCE:

  • Ability to speak, read and write in English; French preferred
  • Lead internal and external auditors in a professional manner
  • Maintain accurate Compliance files and records
  • Perform statistical analysis and defect trending for management review
  • Highly skilled in defining and documenting problems, establishing facts and draw valid conclusions
  • Ability to interpret and report on an extensive variety of technical instructions in mathematical or diagram form while dealing with multiple abstract and concrete variables
  • Ability to problem-solve and multi-task in fast-paced environment

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

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Danaher Corporation Overview

Danaher's Dental Platform is a $3B global business focused on all aspects of dental care. With the intention to spin-off the Dental Platform to become its own public company in the second half of 2019, “Dental Co” will become one of the largest and most innovative dental companies in the world.  We are changing the face of dentistry with our differentiated portfolio of products designed to serve every dental professional’s need. It is our mission to make our dentist's work simpler and better connected so more patients are cared for in a shorter time. Our dental brands include traditional consumables and equipment (KaVo Kerr) and specialty products (Ormco and Nobel Biocare).