
Senior Quality Assurance Professional
23 hours ago
Quality Assurance Specialist
Develop a quality-focused mindset and contribute to the development of innovative products as part of our dynamic product design team.
Our team provides comprehensive design services to leading companies across various industries, including consumer, commercial, sporting and leisure, industrial, automotive, bio-medical, mining applications and more.
Key Responsibilities:
- Championing quality within the organisation, ensuring that it aligns with corporate objectives.
- Developing and maintaining a purpose-built Quality Management System in line with ISO 13485 and ISO 9001 standards.
- Ensuring overall compliance to standard operating procedures in accordance with the QMS.
- Facilitating audit programs and plans, performing internal audits and coordinating external audits.
- Identifying opportunities for improvement in company processes and systems and collaborating with subject matter experts to drive implementation.
- Managing CAPA related activities and facilitating appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development.
- Promoting QMS regulatory requirements to all staff and developing and conducting induction and training on QMS processes and policies.
Requirements:
- Relevant qualification from a reputable education institution.
- At least 5 years' experience in quality management or a similar role.
- In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development.
- Understanding of production/manufacturing processes and ability to communicate effectively with local and offshore suppliers.
- Excellent verbal and written English communication skills and ability to work independently and as part of a team.
Preferred Qualifications:
- ISO 17955 Lead Auditor certification.
- Quality management experience in product design and development.
Work Arrangements:
We offer workplace flexibility by allowing staff to work from home. Permanent and contractor roles are available.
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