Quality Supervisor
- Knowledge of quality standards for medical devices (e.g., ISO 13485, FDA QSR, MDSAP, EU Medical Directives, and Canadian Medical Device Regulations.
- Excellent verbal and written communication skills.
- Excellent organization skills and attention to detail.
- Ability to multi-task.
- Sound, systematic problem-solving skills.
- Strong computer skills: MS Word, MS Excel, PowerPoint, Database Management and Statistical Analysis.
- Able to collaborate with diverse groups of people.
- Strong ability to conduct root cause analyses.
- A minimum of 5 years of Quality System experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485).
- A minimum of 3 years in a leadership role, leading and mentoring employees.
- A minimum of 3 years in quality control and product inspection.
- Bachelor/Associate degree or equivalent work experience.
- Provide clear direction, coaching, and performance management to support team development and achievement of AirLife goals.
- Align team’s objectives with AirLife priorities, ensuring compliance, promoting a culture of accountability, and upholding AirLife values.
- Take accountability and ownership for actively participating in recruitment processes and supporting fair treatment in disciplinary processes for your team.
- Drive continuous improvement by fostering innovation, operational excellence, and adoption of best practices within the team.
- Champion employee engagement, inclusion, and career development through regular check-ins, talent reviews, and succession planning.
- Manage your team’s budget responsibly and exhibit financial accountability.
- Support team through sort and rework activities and ensure adequate resources for completing daily and project-based work punctually.
- Represent customer requirements internally.
- Communicate with outside departments within the plant and in other company facilities to ensure a continuous operational flow.
- Communicate cross-functionally concerning quality and testing issues.
- Lead a team of 1-4 quality control specialists focused on product quality and compliance.
- Provide oversight of activities in the Quality inspection laboratory, and management of all equipment therein.
- Investigate operational and technical issues, leading root cause and troubleshooting activities, resolution of problems, and thoroughly documented activities.
- Owner and leader of nonconformances and CAPAs as it relates to acceptance criteria and distribution processes.
- Ensure compliance to AirLife SOP's and quality control documents for product and manufacturing within the warehouse and distribution centers.
- Utilize data to drive quality control results.
- Report to upper management on the performance of product quality and any need for improvement.
- Support pre-audit and post audit activities and facilitate closure of audit findings impacting relevant facilities and processes.
- Create, identify, and report on quality metrics when necessary.
- Identify areas of opportunity and support continual improvement of the Quality Management System.
- Communicates with all departments to ensure a continuous operational flow.
- Uphold and embody AirLife’s values in all aspects of work.
- Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
- Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
- Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
- Contribute to building and maintaining a positive team environment.
- Assure all policies and guidelines are implemented and followed.
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