Quality Engineer at STIHL responsible for maintaining quality standards for production processes and materials. Leading quality initiatives and audits to ensure compliance in manufacturing operations.
About the role
- Quality Assurance Associate at PolyNovo ensuring compliance and continuous improvement of Quality Management System. Overseeing documentation, change controls, and supporting quality audits in medical devices.
Responsibilities
- Perform the document control function for the company ensuring activities related to document control are compliant with the quality management system procedures and relevant regulatory requirements;
- Draft and maintain quality system procedures and work instructions as required;
- Performs batch disposition and release for supply activities by ensuring batch is produced according to product specifications and marketing authorization;
- Assist with the handling of non-conformances, actively participate in investigations to determine root cause and the implementation of corrective/preventative actions;
- Assist with change controls and project activities;
- Assist in defining key product/service requirements for potential new suppliers as part of the supplier approval process;
- Assist with internal and external audits;
- Support the Change Control process to ensure changes are appropriately risk assessed and that any device design and/or process changes will not impact device safety, performance or efficacy;
- Assist department managers with staff training needs related to the quality management system and maintain the company training matrix;
- Support validation, product temperature excursions and customer complaints activities;
- Comply with all company quality standards, procedures, and workplace health and safety requirements;
- Operate within the requirements of the quality system and ensure responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality processes;
- Manage the development & maintenance of ISO 13485 procedures for regulatory and quality functions that ensure consistency with and compliance to the organization’s Quality Management system.
- Other QA related tasks as required
Requirements
- Diploma qualification (minimum) in a science, biomedical/biotechnology or related
- Preferably 2 years’ experience in a quality related role within a medical device/pharmaceutical manufacturing or engineering organisation regulated by ISO13485 and/or GMP/FDA 21 CFR820
- Understanding of risk management processes and their application within a manufacturing environment.
- Excellent written and verbal communication skills, with the ability to influence others and ensure compliance with requirements.
- Ability to build and maintain effective working relationships across all teams to enable clear and efficient communication.
- Intermediate to advanced proficiency in MS Word and Excel.
- A self-starter who can work autonomously and take accountability for the quality and timeliness of work outputs.
- Exceptional attention to detail in all tasks.
- High level of proactive problem-solving skills to address challenges effectively.
- Demonstrated ability to maintain accurate and comprehensive reporting and documentation standards.
Benefits
- Unique platform technology, an exciting pipeline of highly innovative products
- Diverse, inclusive and flexible workplace culture
- Career development opportunities and unlimited access to online learning
- Rewards platform with access to discounts at over 450+ Australian retailers
- Paid parental leave for primary and secondary carers, Nurture Days, and more
- Salary packaging including novated car leasing
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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