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Quality Assurance Associate
3 months ago
Benefits
- Global pharmaceutical and medical device company.
- Excellent training and development opportunities within the Quality team.
- Opportunity to collaborate with other internal departments.
- Work alongside an experienced QA Manager.
- Diverse and innovative product portfolio.
- Supportive and collaborative team culture.
- Working From Home Flexibility (3 days onsite and 2 days WFH).
- Continuous improvement and development of skillset and knowledge.
About the company
This global company specializes in eye health products and services. With a history spanning over 165 years, the company has a well-established reputation for offering innovative solutions to enhance people's vision.
About the opportunity
As the Commercial Quality Assurance role focuses predominantly on product complaints, and the management of the Quality Management System (QMS) for medical devices and pharmaceutical products. This role involves writing, reviewing, and authorizing quality documents and procedures for ISO9001:2015, facilitating risk assessments, performing audits, and coordinating customer complaints. The ideal candidate must have local commercial Quality Assurance experience, strong attention to detail, excellent communication skills, strong technical writing, and organizational skills.
Duties
- Managing all QMS activities and documentation, such as Change control, NCR, & CAPA etc
- Writing and reviewing quality documents and procedures.
- Conducting internal audits and supporting with external audits.
- Facilitating risk assessment for QMS adhering to the ISO9001:2015 standards.
- Ensuring all employees receive the relevant training as per company standards.
- Overseeing and coordinating customer complaints for medical devices and pharmaceutical products.
- Collaborate with internal departments and 3rd party suppliers to ensure complaints are accurately managed and compliant with the company standards.
**Please note, the ideal candidate has unrestricted working rights in Australia
Skills and Experience
- Tertiary University degree or equivalent.
- Minimum 2 years of Local Commercial QA experience in Pharmaceutical or Medical Device industries.
- Strong understanding of change control and document control processes within the pharmaceutical industry.
- Solid knowledge of product complaint processes for Medical Devices.
- Knowledge of ISO9001:2008 or ISO9001:2014.
- Excellent verbal and written communication skills.
- Ability to multi-task and prioritize important tasks.
Culture
This company's culture prioritizes innovation, collaboration, and a dedication to improving lives while embracing diversity, teamwork, and maintaining ethical business practices.
How to Apply
Click apply or email Tamara El Husseini, Recruitment Consultant on telhusseini@hpgconnect.com for a confidential discussion.
