Quality Specialist Auditor
Mississauga, ON, Canada
Req ID 51113BR
Business Title
Quality Specialist, Auditor
Business
Global Quality
Sub-Business
LAC Support
Country
Canada
State/Province
Ontario
Location of Position
Mississauga, Ontario, CAN
Shift_
1st
Job Description
•Responsible for Assessment Program (internal and supplier) to ensure compliance to Corporate Quality Manual, Health Canada, Corporate and TUV requirements.
•Schedules, coordinates and performs internal and supplier compliance audits per schedule.
•Determines through observations, in-depth employee interviewing and flow charting, the issues and elements of the process or system which potentially prevents an individual from performing a function correctly or act as a deterrent to the proper performance of the function.
•Create audit reports based on assessment findings and report to management representative.
•Maintains a follow-up system for unresolved issues.
•Maintains an audit database to allow for ease of accessibility and retrieval of audit results and management requested reports
•Manages the audit-readiness team and trains other audit team members
•Utilize the Global Supplier Quality Trackwise System (GSQTS) for maintaining Supplier Quality Records
•Conducts Supplier Quality re-evaluations
•Ariba - Baxter Buy Right Purchasing- approving and evaluating purchasing requests for Quality impact.
•Communicate with suppliers to obtain required information and/or documents
•Analyze supplier related defect data to determine root cause
•Understand and assure conformance to regulations for suppliers
•Assist with business requests and supporting business related projects related to supplier quality
•Managing/Assessing supplier quality requirements, including writing Quality Agreements
•Requires up to 30% travel, including potential international locations
•Ensure assessment program is compliant to Corporate Quality Manual, Health Canada, Corporate and TUV requirements.
•Schedules and coordinates inspections with internal customers and suppliers
•Performs internal and supplier compliance audits per schedule.
•Reviews and analyzes audit results
•Maintains a follow-up system for unresolved issues.
•Maintains an audit database to allow for preparation of audit reports for management review
•Utilize the Global Supplier Quality Trackwise System for maintaining Supplier Quality Records
•Conducts Supplier Quality re-evaluations
•Communicate with suppliers to obtain required information and/or documents
•Analyze supplier related defect data to determine root cause
•Understand and assure conformance to regulations for suppliers
•Writing Quality Agreements/assessing supplier requirements, liaising with external suppliers
•Remains current with respect to regulatory trends and divisional issues.
•Participates on the corporate quality council as required. Partners with facilities, divisions, and regions to ensure successful implementation and compliance to CQP / regulations
•Assist with business requests and supporting business related projects related to supplier quality
•Manages the audit-readiness team and trains other audit team member
•Leads and participates on continuous improvement projects with the objective of achieving quality, reliability and cost improvement
•Completes requested month end summary/metric reports for Management Review meeting
Job Requirements
Required:
•Bachelor of Science (BSc, BASc, or related field) or College Diploma with demonstrated equivalent experience
•3-5 years experience in Quality, Manufacturing, Engineering or related field
•Must be willing to travel up to 30%
•Strong / Proven Communication and Technical writing skills
•Strong understanding of GMPs and Medical Device Regulations (ISO 13485 standard)
•Manufacturing process
•Quality Operations in a GMP environment
•Quality Systems in a GMP environment
•3-5 years
•Strong understanding of Health Canada GMP and Medical Device Regulations
•Thorough knowledge of applicable procedures, specifications, regulations and standards
•Strong analytical and problem solving skills
•Good communication
•Good interpersonal/influencing/negotiation skills
•Good project management skills
•Computer skills in MS Office (Word, Excel, Windows, Access) and Windows operating system
•Excellent communication skills
•Good knowledge of Quality Trackwise System
•Must be able to travel up to 30% Preferred:
•Bachelor of Science (BSc, BASc, or related field)
•Drug or Biologic Manufacturing / Operations Experience Preferred
•1-2 years of auditing experience
•Laboratory Experience
•Must be able to clearly document audit findings within audit reports
•Ability to build relationships across functional boundaries at multiple levels internally and externally
•Strong analytical and problem solving skills
•Thorough knowledge or applicable procedures, specifications, regulations, and standards
•Proficient in Trackwise GSQ, SAM, EAM, IAM, and ARIBA Spend Management
•Certification as Quality Auditor from an accredited organization
•Auditing experience
•Medical Device Experience
•5+ years
•Ability to respond to internal and external customers in a timely manner
•Ability to solicit feedback and information from others in an open environment
•Ability to build relationships across functional boundaries at multiple levels internally and externally
•Excellent knowledge of Quality Trackwise System
