The primary objective of this role is to manage the Team effectiveness in the performance of releasing components in Goods Inwards and products daily and ensures that they are carried out with approved written Procedures, Work Instructions and Specifications. In addition, the role ensures the QC team operates effectively within a cross-functional environment ensuring the requirements of the GMP regulations and ResMed QMS are met and support the Production Focus Teams (PFT) in meeting the KPI’s of Quality, Delivery and Cost.
The QC Team Leader provides and monitors appropriate training to all QC personnel and is in charge in the maintenance of the QC Area and its Equipment.
In addition, this role will provide leadership and guidance to ensure the Calibration System is maintained and remains compliant to the regulations
Let’s talk about Responsibilities
Team Leadership
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Provides the Team support and motivation it needs to achieve its common goal to complete required tasks
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Ensure conformity and adherence to quality procedures
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Facilitate QC inspectors and provide direct guidance/coaching to respective personnel development.
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Review and support team members’ development, identifying training and providing opportunities to broaden experience; provide leadership, mentoring and guidance; and keeps training records up-to-date in LMS
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Perform training for Procedures and Product Specifications relevant to the QC function for new and revised documents and ensure the awareness of staff to changes in the system.
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Build collaborative relationships with key stakeholders to meet daily requirements, to drive improvements and to ensure adherence to Quality and GMP requirements
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Provide leadership and support to calibration team to ensure compliance and maintenance of the Calibration Management System and explore CI opportunities as appropriate
QC Inspection and Reporting
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Manage processes and procedures related to the QC Good Inwards and Production activities and ensures such processes compliance to QMS Policies and Procedures
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Manage day to day issues raised as a result of QC activities in Goods Inwards and Production; be responsible for the coordination of component, in-process and finished goods inspection and resolve quality issues with sound problem solving techniques.
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Ensure maintenance, filing and archiving of all records associated with the inspection process and tasks are performed timely reducing back log
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Ensure nonconforming product is appropriately managed and NCD’s in Goods Inwards and Production are investigated timely with appropriate evaluation and disposition.
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Improve existing Quality Control processes and procedures related to Goods Inwards, in-process inspection and final inspection and provide monthly reports and tracking and trending data against KPIs incorporating SPC
OHS
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Takes active involvement in the rehabilitation of injured personnel
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Understands the responsibilities associated with Duty of Care.
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Ensure staff work safely to prevent manual handling injuries; take active involvement in the prevention of OH&S hazards
GMP / Housekeeping
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Ensures that quality standards required by GMP and 5S are followed.
Let’s talk about Qualifications and Experience
Required:
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Degree/Diploma in Engineering or Science with at least 2 years industrial experience.
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Experience in volume manufacturing.
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Good Knowledge of FDA Quality System Regulations, GMP and appropriate ISO Standards.
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Understanding of total quality and best practices
Preferred:
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Experience in people management
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!
Top Skills
What We Do
ResMed provides medical equipment for treating, diagnosing, and managing sleep-disordered breathing and other respiratory disorders.