Job Description:
1. Training Administration Support
- Support site training administration in collaboration with the Quality Lead.
- Assist in maintaining the training system to ensure all site associates are assigned, completed, and compliant with required training.
2. Document and Record Control
- Accurately document inspection and verification results in SAP and on controlled forms or data sheets.
- Maintain quality records to demonstrate conformity to product, process, and regulatory requirements.
- Support document control activities, including issuance, revision, and archival of records.
- Participate in the development, review, and update of inspection procedures, protocols, and checklists.
3. Complaint Handling, Incident Reporting, Field Action & Recall Support
- Support complaint handling activities related to warehouse and inventory operations.
- Coordinate with the Quality Lead to support nonconformance reports related to returns, field actions, and recalls.
- Perform inventory checks and quarantine activities for nonconforming or returned products.
4. Warehouse Quality & Inventory Support
- Support controlled distribution and inventory management for finished products in accordance with GMP and company procedures.
- Monitor warehouse environmental control systems, including temperature and other conditions for sensitive materials.
- Support warehouse inspections, cleaning logs, pest control programs, preventive maintenance, and equipment calibration activities.
- Manage and track nonconforming inventory, including short shelf‑life products.
- Identify and support continuous improvement opportunities within warehouse and quality control processes.
5. Product Receiving, Shipping Inspection & Release
- Inspect incoming and outgoing products to verify compliance with purchase orders, specifications, labeling, and regulatory requirements.
- Perform visual inspections of packaged products to confirm correct labeling, packaging integrity, and absence of visible defects.
- Accept and release compliant product or place product on hold/reject status when specifications are not met.
- Communicate quality concerns and inspection findings to the Quality Lead and support resolution activities.
6. Nonconformance & Deviation Management
- Manage product and process nonconformances in accordance with approved procedures.
- Control and track nonconforming finished goods and returned products.
- Support deviation investigations, root cause analysis, and corrective actions.
- Communicate quality issues with operators, packers, warehouse staff, and the Quality Lead to drive timely resolution.
7. Audit Support
- Support preparation and coordination of internal and external audits.
- Ensure records, logs, and inspection evidence are complete, up‑to‑date, and audit‑ready.
- Support audit responses and corrective action follow‑ups as assigned.
Job Requirements:
- 2 to 3 years of quality assurance and quality control experience preferred.
- Bachelor's Degree or Post-secondary education in a relevant field.
- Working Knowledge of Health Canada Medical device regulation, ISO 13485 standard, Quality System Regulation requirements, Canada Food and Drug Reg. and Good Manufacturing Practices.
- Experience in the Training systems, Inspection, warehouse distribution, inventory management, Nonconforming product, and complaint investigations.
- Proficiency skills in MS Office (EXCEL- pivot tables, Word, PowerPoint) and experience in SAP/Oracle. Experience of warehousing and storage of medical devices (Temperature requirements and system monitoring)
#LI-TP1
IND123
Operating Company:
Nobel Biocare
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
