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Quality Manager

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Location
Toronto, ON
Job Type
Direct Hire
Date
Mar 12, 2018
Job ID
2549732

JOB SUMMARY:


As Quality Manager, you will oversee the Quality Management System and the team responsible for quality control and quality assurance. As well you will be an integral contributor to a dynamic, cross-functional team of technical, clinical, QA/RA, and marketing individuals devoted to developing advanced product solutions for better patient outcomes. 
 
Day to day duties will include managing the team developing and maintaining the Quality System procedures/processes and the team responsible for Quality Control testing, as well as acting as QA subject matter expert when collaborating closely as with personnel in other functional units, representing QA in Project Teams. This is a challenging role and the right candidate will play a major part in the success of this fast growing OEM
 

RESPONSIBILITIES:
 
  • Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
  • Manage activities related to quality management subsystems including CAPA, NCR, Complaints, Change Control, Supplier Management
  • Manage Quality Control activities including defining priorities, overseeing testing (validation, finished product & stability), evaluating results, trends & OOS’s.
  • Lead efforts to obtain ISO 13485:2016 and MDSAP certification in 2018
  • Active participant in all stages of design development, V&V testing, design control and process validation activities, ensuring quality assurance considerations and requirements met 
  • Manage the analyses and trending of quality assurance metrics
  • Participate in Risk Management activities and ensure compliance to standards and regulations
  • Lead, coordinate and conduct quality system audits and supplier audits, as necessary
  • Lead activities related to implementation of UDI requirements
  • Employ quality assurance methodologies in support of product development, manufacturing and regulatory functions
  • Facilitate and implement changes and improvements to the quality system to ensure the effective and efficient operation of the quality system.
  • Serve as quality management representative  
  • Develop quality plans and recommendations for improvement
  • Supervise, guide and coach direct reports
  • Other tasks as assigned

REQUIREMENTS:

 
  • Bachelor’s degree with 7-10 years of industry experience, with a minimum of 5 years or more experience in a FDA QSR and/or ISO 13485-compliant environment
  • Process orientated, logical, analytical, meticulous, highly organized and able to analyze data & implement solutions
  • Excellent high level oral & written communications skills enabling incumbent to act as a facilitator and/or educator with strong leadership skills
  • Proven ability to lead, mentor and develop a QA/QC team

HIGHLY DESIRED QUALIFICATIONS:

 
  • Certified Auditor
  • Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project programs
  • Demonstrated project management skills and experience.
  • Exceptional problem-solving skills and ability to “think outside the box”
  • Proficient in timely review of technical and clinical data.
  • Self-motivated and self-directed
  • Ability to handle and prioritize multiple tasks

 


ABOUT US

KNG gets high demand for professionals in R&D, Engineering, Chemistry, Science and technology, manufacturing, Quality, Regulatory affairs, Process, and Facilities.

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