NIPRO Canada is a long-standing customer focused company providing healthcare products and development in the global healthcare market.
About the Role:
As Production Manager, you will be responsible for daily operation of all medical device manufacturing.
The Production Manager will work cross-functionally with Quality Assurance/Regulatory Affairs, R&D/Engineering, Supply Chain, Warehouse, Maintenance, and Planning to support production output, ERP transaction accuracy, inventory availability, production document control, material flow, process improvements, nonconformance resolution, training, equipment readiness, auditing and continuous improvement initiatives.
This position requires strong hands-on leadership, experience using ERP/MRP systems, knowledge of inventory control practices, and the ability to maintain accurate production records in compliance with medical device quality system requirements.
In this role, you will report to the Director of Operations.
Production Leadership
- Manage daily manufacturing operations to ensure production schedules, output targets, quality requirements, and delivery commitments are met.
- Lead, coach, and develop production supervisors, assemblers, and other manufacturing personnel.
- Monitor production priorities, staffing levels, inventory availability, equipment readiness, and customer demand.
- Monitor production performance and take corrective action when output, yield, quality, inventory accuracy, documentation accuracy, or efficiency targets are not being achieved.
- Ensure production areas are organized, clean, safe, audit-ready, and compliant with applicable procedures and Good Manufacturing Practices.
ERP / MRP System Management
- Use ERP/MRP systems to review production orders, work orders, bills of materials, routings, material requirements, inventory status, labor reporting, and production schedules.
- Ensure timely and accurate ERP transactions related to production order release, material issuance, work order completion, scrap reporting, labor entry, inventory movement, and finished goods transfer.
- Partner with Planning, Supply Chain, Warehouse, and Finance to support accurate inventory records, production costing, work order closure, and material availability.
- Review on daily basis ERP data for accuracy and resolve discrepancies related to production orders, material consumption, inventory balances, lot tracking, and production reporting.
- Support ERP process improvements, system discipline, user training, and data accuracy initiatives within the manufacturing team.
Production Document Control
- Ensure all production documentation is completed accurately, legibly, and on time in accordance with company procedures and applicable regulatory requirements.
- Oversee proper use and control of production documents, including work orders, travelers, batch records, device history records, line clearance forms, inspection records, labels, routers, and controlled work instructions.
- Ensure manufacturing personnel are using current, approved versions of procedures, specifications, drawings, forms, labels, and work instructions.
- Partner with Quality Assurance and R&D/Engineering to manage documentation updates, production record corrections, document revisions, training requirements, and document change implementation.
- Review production documentation for completeness, accuracy, traceability, and compliance prior to submission to Quality or final release.
- Support document control practices related to lot traceability, material reconciliation, labeling control, nonconformance records, deviations, and device history records.
Inventory Control and Material Management
- Oversee raw material and production supplies inventory control activities to ensure accurate material usage, lot traceability, material reconciliation, and inventory transactions.
- Ensure raw materials, components, subassemblies, WIP, finished goods, labels, packaging materials, and consumables are properly controlled, identified, stored, issued, and reconciled.
- Partner with Warehouse, Supply Chain/Purchasing, and Planning to maintain material availability and minimize production delays caused by shortages, incorrect inventory, or material handling issues.
- Monitor production floor inventory, WIP level, point-of-use inventory, material staging, and returned materials.
- Ensure obsolete, expired, rejected, quarantined, or nonconforming materials are properly segregated and controlled in accordance with quality procedures.
- Support cycle counts, physical inventory activities, inventory variance investigations, and corrective actions related to inventory discrepancies.
Quality and Compliance
- Ensure all manufacturing activities are performed in accordance with approved SOPs, Design Master Record (DMR), work instructions, device history records (DHR), travelers, and quality system requirements.
- Promote adherence to medical device quality standards, including ISO 13485: 2016, FDA 21 CFR Part 820 / QMSR, CMDR, and other applicable regulatory requirements.
- Support accurate documentation, lot traceability, labeling controls, line clearance, inventory reconciliation, material traceability, and production record completion.
- Partner with Quality Assurance to investigate nonconforming product, deviations, complaints, CAPAs, audit findings, documentation errors, inventory discrepancies, and process issues.
- Ensure production personnel are properly trained and qualified before performing assigned tasks or using controlled documentation, training records and ERP transactions.
- Participate and support annual internal audit and external audit
- Support routine cleaning, environmental monitoring, process validation, equipment qualification, and cleanroom certification processes.
- Ensure validation samples for Bacterial Endotoxin Testing, Bioburden testing and other validation processes be completed on timely basis.
Continuous Improvement
- Identify and implement improvements to increase productivity, reduce scrap, improve yield, reduce downtime, improve inventory accuracy, strengthen document control, and enhance overall manufacturing performance.
- Develop and propose improvement tools to drive operational excellence.
- Support manufacturing transfers, new product introductions, ad-hoc sample assembly, customized production, and scale-up activities as needed.
- Collaborate with Engineering and Maintenance to troubleshoot equipment, tooling, fixture, and process-related issues.
- Identify opportunities to improve ERP workflows, production documentation, material flow, inventory accuracy, and production reporting.
People Management
- Recruit, train, supervise, evaluate, and develop production team members.
- Set performance expectations and provide regular feedback, coaching, and corrective action when necessary.
- Build a culture of accountability, safety, quality, documentation accuracy, inventory discipline, teamwork, and continuous improvement.
- Manage timekeeping, attendance, shift coverage, overtime, and staffing requirements.
- Ensure effective communication across departments, including production status, material shortages, documentation issues, ERP transaction issues, and quality concerns.
Safety and Operational Controls
- Ensure production employees follow all company safety policies, PPE requirements, equipment procedures, and environmental controls.
- Support cleanroom, controlled environment, sterilization, packaging, labeling, or assembly requirements where applicable.
- Ensure equipment, tools, fixtures, controlled documents, inventory, and production areas are maintained in a state of readiness.
- Escalate safety, quality, equipment, material, documentation, inventory, ERP, or staffing issues in a timely manner.
Supervisory Responsibilities:
- Direct supervision of Material Handler, Cleanroom Supervisor and Cleanroom staff.
Education and Experience:
- Bachelor's degree in Engineering, Manufacturing, Operations Management, Life Sciences, Business, Supply Chain or a related field (Equivalent experience may be considered)
- 5+ years of manufacturing experience, with at least 2-3 yrears in a supervisory or managerial role
- Experience in sterile medical device, pharmaceutical, biotechnology, diagnostics, electronics, or another regulated manufacturing environment is an asset.
- Hands-on experience using ERP/MRP systems to manage production orders, inventory transactions, material requirements, work order status, production reporting, and inventory control.
- Experience with production document control, including work orders, travelers, device history records, batch records, controlled work instructions, production forms, and documentation review.
- Strong understanding of inventory control, material movement, lot traceability, WIP control, material reconciliation, cycle counting, and inventory accuracy.
- Working knowledge of ISO 13485, FDA 21 CFR Part 820 / QMSR, GMP, GDP, CAPA, nonconformance handling, and production documentation requirements are preferred.
- Strong leadership skills with experience managing production teams in a fast-paced environment.
- Ability to read and understand work instructions, specifications, drawings, bills of materials, routings, production travelers, and quality documentation.
- Experience with production planning, labor management, inventory coordination, ERP transactions, and manufacturing performance metrics.
- Strong problem-solving, conflict resolution, communication, and cross-functional collaboration skills.
- Proficiency with ERP/MRP systems, Microsoft Office, and production reporting tools.
Equity and Accessibility Statements:
Nipro Canada Corporation provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any time without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, provincial, or local laws. Accommodations for individuals with disabilities will be made upon request at any stage in the recruitment, selection, onboarding or employment lifecycle.
This posting is for a currently open position.
Pay: $80,000.00-$85,000.00 per year
Benefits:
- Casual dress
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care
Work Location: In person
