Production Quality Specialist

TOGETHER, WE SAVE LIVES

OVERVIEW
This position reports to the Plant Manager with dotted line responsibility to the Director of Quality. The incumbent is responsible for maintaining the effectiveness of the production facility’s Quality Assurance System including overall product manufacturing quality control. The Quality Specialist is involved with internal process and product auditing, First Article Inspection and/or Testing (FAI/T) problem solving and providing solutions for process issues, product issues, including documentation and communication of these issues to various levels of the facility.
The Quality Specialist supervises the QC inspection staff, provides Quality Systems orientation to new hires, is responsible for supporting corporate Quality Systems with the planning and execution of local system, process and product audits, managing the facility’s calibration program, coordination of test sample preparation and coordination of local Material Review Board (MRB) activities associated with disposition of nonconforming product. This position also provides local leadership in various aspects of ISO 9001(latest version) requirements and certified product compliance, manufacturing/product monitoring and testing coordination, local liaison with certification bodies and customers, documentation review / approval and new product introduction planning. This position works closely with Product Quality Specialists, Manufacturing Specialists, Procurement, New Product Introduction (NPI) Configuration Management and Engineering functions
RESPONSIBILITIES
QUALITY CONTROL/COORDINATION (60%)
- Oversees and coordinates QC activities
- Provides clear direction to QC staff of inspection practices and standards
- Local MRB QC representative - disposition of nonconforming product and material
- Manages NCRs using Q-Pulse (Compliance Management software) and controls nonconforming product segregated in the Quarantine area
- Coordinates timely resolution of incoming inspection issues with purchasing department, Quality Engineering and Vendors
- Conducts Process Audits in support of Quality Systems Management, coordinates corrective action teams and ensures accurate documentation and required information is accessible to production
- Assists Production Manager and Manufacturing Engineering in operator certification
- Responsible for new hire Quality Orientation
- Accurately documents product issues and communicates clearly to various stakeholders
- Leads or assists with root cause analysis investigations for product manufacturing quality issues
- Oversees and ensures the effectiveness and reliability of the facility’s inspection process. Compiles data on overall product and supplier quality performance (weekly Factory Product Inspection and monthly Incoming Inspection reports)
- Oversees the generation and sign off of Certificate of Conformances for Sales Orders
- Audits Sales Orders for completion and compliance to order customer requirements
- Collects and manages supplier and factory inspection and test data in support of program / project requirements
- Manages the local monitoring and measurement equipment calibration program using Q-Pulse
- Assists in evolving the QC controls at Incoming and Production (In-process and Final)
- Assists in creating or updating inspection instructions, samples, records, and quality documentation for new and existing products
- Co-ordinates and ensures part approvals / FAIs for outsourced and internally manufactured items are completed
- Conducts or co-ordinates source (at supplier) inspections as required
- Coordinates Customer / Gov’t inspections at facility

QUALITY SYSTEM MAINTENANCE | CONTINUAL IMPROVEMENT & CORRECTIVE ACTION SUPPORT (40%)
- The main point of contact for local internal and external systems audits
- Co-ordinates resolution of corrective actions or issues raised during audits
- Provides guidance on product issues
- Conducts Root Cause investigation on product and process issues
- Participation in Facility Continual Improvement / Lean projects
- Assists Customer Service on inspection of RMAs, trouble shooting and conducting root cause investigations on customer complaints and faulty products

QUALIFICATIONS
- Technical certificate/diploma in têxtile, mechanical, electronic or equivalent discipline, or combination of Med-Eng product knowledge and experience.
- WHIMIS, ESD and health and safety training
- Strong knowledge of the fundamentals of Quality Assurance including Calibration and product / process auditing
- External certifications (e.g., ASQ) Internal Auditor, Calibration Technician, Quality Technician, etc. would be a benefit
- 5-7 years’ experience in a quality assurance position in a manufacturing environment.
- 1-3 years supervisor experience in a manufacturing environment.
- Strong knowledge of ISO 9001:2015 Quality Management Systems Requirement Standard or exposure to an ISO 9001 and/or equivalent certified PPE manufacturing environment, e.g