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Quality & Regulatory Engineer

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Location
Toronto, ON
Job Type
Direct Hire
Date
Mar 15, 2017
Job ID
2457845
Establishing, implementing, coordinating and guiding the internal quality processes to ensure an effective Quality Management System (QMS) that meets worldwide quality and regulatory requirements for medical devices.
 
Duties/Responsibilities
 Development and achievement of quality objectives in the area of quality assurance and quality management activities across the Company
 Develops and implements Quality Management System (QMS) needed to meet ISO 13485 and FDA QSR regulations
 Develops, defines, maintains and revises processes, Quality Manual and QMS procedures to ensure Company and products are compliant with applicable regulations and laws
 Maintain system and processes for all Quality related document management of the company
 Establishes quality metrics to ensure effective adoption and implementation of QMS requirements across Company
 Prepares audit schedules, executes internal audits and evaluating audit reports and ensures necessary validations are performed on equipment, processes and software used in manufacturing and product testing
 Leads product and facility inspections, preparation of procedures and instructions including certification assessment and surveillance audits, FDA inspections, and other regulatory inspections and supplier audits
 Works with Supply Chain and Manufacturing leads to develop, implement Supplier Quality program including material qualifications, setting of material specifications and test methods for incoming goods. Develop schedule and lead supplier audits and qualifications.
 Facilitates internal pFMEA and dFMEA processes.
 Provide support to manufacturing and engineering ensuring consistent application of quality techniques
− Resolve quality issues of capability, tolerancing, and material related issues
− Resolve quality issues by identifying problems, examining solution options, implementing action plans, and providing resources. − Effectively communicate and reinforce the commitment to quality improvement efforts.
 
SME responsible for quality related issues, including communication with Notified Body, FDA, etc. on quality related issues
 
 
Knowledge/Skills/Abilities
Required Qualifications:
Bachelor’s degree in Engineering
5 years of experience in Quality Assurance and Quality Management with 3+ years in medical device industry
Experience leading the implementation of QMS, process design, quality assurance initiatives for medical devices in ISO13485 regulated environments
Experience with design transfer of medical device like products from research to manufacturing.
Experience of audits by regulatory authorities. Experience hosting/leading FDA and other regulatory audits
Teamwork-oriented approach to achieving critical milestones
 Excellent written and verbal communication skills
 Problem solving ability and lateral thinking capability
 
Proven ability to work in a fast-paced environment with short deadlines to accomplish objectives
Ability to communicate effectively with technical and non-technical personnel.
 
 

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