Software Development

Quality Assurance Manager

Job ID# 0910-2

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Position Type:	Full time
Duration:	Permanent
Location:	Toronto (GTA)
Salary:	$60,000

 

Required IT and Occupational Skills				Other Related Skills
Post-Secondary Education Expertise in preparing medical device regulatory submissions for North American and European markets Minimum 5 years experience in managing an ISO 9001/13485 quality system Knowledge of validation and verification process including risk management summary Electrical and/or Software Engineering experience Experience as a Systems Analyst Familiarity with IEC 60601 series standards or equivalent				Commitment to quality Strong technical writing capabilities Strong Interpersonal skills Excellent problem solving abilities Ability to work independently with minimal supervision Experience working with MS Office and Visual Source Safe

Quality Assurance Manager

Location: Toronto

Role Summary:
We are looking for a well organized self starter to prepare and submit medical device regulatory applications, to administer and upgrade its existing ISO 13485/CE quality system, and to support the product validation and verification process.

Main Accountability:

• Prepare and submit regulatory submissions; U.S. FDA 510(k), EU Technical File, Canadian Medical Device License, etc.

• Maintain Quality Manual, SOP's, and Work Instructions

• Develop product specific verification and validation plans and procedures

• Act as lead on scheduled and unscheduled quality audits from notified bodies and regulatory authorities

• Work with all departments to continually improve quality process

• Train staff members on quality system

• Chair semi-annual management review meetings

 

Must Have Skills/Experience:

• Post-Secondary Education

• Expertise in preparing medical device regulatory submissions for North American and European markets

• Minimum 5 years experience in managing an ISO 9001/13485 quality system

• Knowledge of validation and verification process including risk management summary

• Electrical and/or Software Engineering experience

• Experience as a Systems Analyst

• Familiarity with IEC 60601 series standards or equivalent

• Commitment to quality

• Strong technical writing capabilities

• Strong Interpersonal skills

• Excellent problem solving abilities

• Ability to work independently with minimal supervision

• Experience working with MS Office and Visual Source Safe

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