Senior Quality Assurance Specialist
We are seeking an experienced Senior Quality Assurance Specialist to spearhead the development and maintenance of quality systems that support our organisation’s growth.
* Main Responsibilities:
* Lead the development and maintenance of quality systems in accordance with ISO 13485:2016 and 21CFR Part820 regulations.
* Manage document control, ensuring all documents are processed consistently and compliantly.
* Represent the quality function at functional team meetings, providing advice and documentation reviews.
* Participate in risk management processes to identify and mitigate risks in compliance with ISO 14971:2019.
* Liaise with technical operations to ensure high-quality product delivery.
* Prepare quality system metrics for senior management meetings.
* Address customer complaints and ensure vigilance and reporting requirements are met.
* Develop and implement CAPA systems and maintain internal audit systems.
* Support supplier management programmes and prepare reports as required.
* Complete additional tasks as designated by your supervisor.
Requirements
* Bachelor's Degree: Science or Engineering discipline.
* Experience: Minimum eight years in quality assurance or regulatory roles, preferably in the medical device industry.
* Skillset: Excellent written, interpersonal communication, and presentation skills.
* Personal Qualities: Self-motivated, able to deliver work required to advance company objectives with minimal direction.
* Team Dynamics: Strong ability to participate in teams delivering outstanding results.
* Prioritization: Able to prioritize and focus on critical objectives amidst numerous project tasks and activities.