Our organization is seeking a Quality Assurance Specialist for an initial 12-month contract with potential to become permanent.
The Role
This position supports the Quality Manager in maintaining quality management systems and working on moderately complex quality projects.
Key Responsibilities
* Apply expertise in quality and problem-solving skills to handle intricate situations.
* Identify problems and possible solutions, then take action to resolve them.
* Utilize data analysis skills by resolving missing or incomplete information.
* Seek consensus for decisions under uncertainty and apply risk assessment techniques.
* Drive business improvements through continuous improvement initiatives.
* Evaluate quality-related non-conformances and CAPAs.
* Ensure cross-functional compliance for multi-site ISO13485 certification.
Requirements
* A degree from a recognized institution is required.
* A minimum of five years of experience in the medical device industry, with at least three years of progressively responsible positions.
* Strong knowledge of recognized quality management systems (e.g. ISO9001/ ISO13485/ ISO14971).
* Familiarity with relevant laws and regulations (e.g. CE/ FDA).
* Thorough knowledge of engineering and technical applications applied in medical device development.
* Excellent interpersonal, written, and verbal communication skills.
* A proactive attitude, strong organizational skills, and ability to manage multiple projects.
* Proficient in MS Word, Excel, Power Point, and spreadsheet management.