Quality Manager

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This range is provided by TekniPlex. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$82,500.00 / yr - $95,000.00 / yr

The QA Manager is the appointed Management Representative for Quality with associated responsibilities and authority. This position has the Quality Authority for final disposition decisions of all materials and product. The Quality Manager reports directly to the Quality Director and has overall responsibility to make decisions and take action so that quality standards are maintained and continuously improved.

• Manage site's Quality Management System using Intelex (eQMS software).
• Evaluate KPIs by completing monthly and annual KPIs.
• Drive improvements to ensure compliance to site's quality objectives.
• Responsible for assuring products meet internal and external quality requirements
• Coordinate Corrective Action activities.
• Selection and maintenance of tools, inspection systems, and associated equipment
• Responsible for oversight of supplier quality, including supplier approval, complaints, and audits.
• The evaluation and review of quality requirements.
• Communication with customers regarding complaints, change control, etc.
• ISO Management Representative; Responsible for QC participation / compliance with GMP and other programs.
• Participate in cross-site internal audits of other TekniPlex Healthcare locations
• Plan, host, and coordinate Internal, Customer, and annual ISO15378 and ISO22716 audits.
• Supervisory oversight of quality team including performance management
• Responsible for participating in the facility's Safety and Environmental programs to ensure a safe work environment.
• Promote worker safety by :
• Actively assesses activities on a constant basis to ensure no unsafe actions or results will occur.
• Stressing safe working practices as a condition of employment to associates.
• Leading audit initiatives of employee behaviors to ensure compliance with safety rules and guidelines, as well as housekeeping audits and surveys.
• Ensuring the housekeeping in the facility is maintained or improved to the highest level possible.
• Ensuring that all corporate initiatives are followed as appropriate
• Ensures Quality products and processes are maintained by :
• Understanding and supporting both quality policies and the Quality System.
• Performing work at a level that ensures quality of this position's work meets or exceeds internal and external customer specifications.
• Identifying and correcting, where possible, any identified quality issues throughout the plant.
• Development and implementation of quality training.
• Participating in system or quality-based training provided or recommended by the company.
• Actively participates in the continuous improvement process by :
• Identifying and addressing any opportunities to reduce cost, improve product repeatability & reliability.
• Lead and or champion CI teams to eliminate problems, streamline operations or other areas as defined by management.
• All other duties as assigned.

Job Qualifications, Equipment and / or Experience :

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