Job Overview
We are seeking a highly skilled Quality Assurance expert to join our team. The successful candidate will support the Quality department, Manufacturing department and R&D Department in ensuring compliance with regulatory requirements.
Key Responsibilities
* Support the review and approval of manufacturing documentation including SOPs, work instructions, and batch records.
* Review and release of raw materials, components and finished goods against raw material specifications, and in-process and final QC criteria.
* Assist in the training of staff on quality assurance procedures and regulatory requirements.
* Maintain accurate and organized records of quality assurance activities and findings.
* Issue new or revised controlled documents to the Manufacturing department and remove obsolete documents.
Quality System
* Assist the Quality Department in the implementation, and maintenance of Quality Management Systems (QMS) in accordance with:
o ISO 13485
o Current Good Manufacturing Practices (cGMP)
* Assist the Quality Department with internal audits to ensure compliance with regulatory standards and company policies.
* Participate in the investigation and resolution of company-wide non-conformances, CAPAs (Corrective and Preventive Actions), deviations, change control and customer complaints.
* Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle.
* Support continuous improvement initiatives to enhance product quality and operational efficiency.
* Support supplier qualification and performance monitoring programs.
* Participate in risk management activities, including FMEA and hazard analysis.
Laboratory Operations
* Assist and help maintain laboratory inventory, including incoming goods, goods in use and quarantine processes.
* Assist in ordering consumables and raw materials required for research and product development activities.
* Support in authoring quality process documents relating to laboratory operations.
* Manage the verification and validation of infrastructure and equipment through installation qualification / operational qualification / performance qualification (IQ/OQ/PQ) validation process.
Requirements
* Bachelor's degree in a relevant field (e.g., Biotechnology, Science, Biology, Chemistry, Biomedical Engineering).
* A minimum of 3 years of experience in quality assurance, preferably in the medical device or in vitro diagnostic industry.
* Knowledge of ISO 13485 and cGMP.
* Strong attention to detail and organizational skills.
* Excellent communication and interpersonal skills.
* Ability to work collaboratively in a team environment.