Quality Assurance Specialist

Job Description

Competitive salary and benefits package, including a pension scheme and private medical insurance.

Our company is seeking a Quality Specialist to join our team and support our ISO 13485 quality management system.

The ideal candidate will be a self-starter with critical analytical skills and attention to detail, capable of document control, software validation, and implementation of QMS procedures.The successful candidate must have knowledge of CAPA, nonconformance, SCAR, and change control processes, as well as the ability to work collaboratively with others and take initiatives.

Key Responsibilities

• Authorship in QMS implementation including validation. Leading training sessions within an ISO 13485 environment.
• Provide support with internal and external audits.
• Provide critical analytical skills to help identify potential quality issues and take corrective actions.
• Work collaboratively with others to ensure effective communication and successful outcomes.
• Monitor and analyse quality data to identity trends and opportunities for improvement.
• Provide support to CAPA, nonconformance, SCAR and change control processes.
• Demonstrate a self-starter mentality and be proactive in identifying and resolving quality issues.
• Manage and prioritize multiple tasks, projects, and responsibilities simultaneously.
• Continuously seek out opportunities for growth and development to enhance knowledge of quality management practices.

Experience

• Minimum 3-5 years of experience in a quality management role within an ISO 13485 environment or Pharmaceutical GMP environment.
• Knowledge of quality management processes, including CAPA, non-conformance, SCAR and change control.
• Strong analytical and problem-solving skills with the ability to make sound decisions based on data analysis.
• Detail-oriented with strong organizational skills and ability to prioritize tasks and meet deadlines.
• Excellent communication skills, both verbal and written.
• Experience of writing procedures from scratch.
• Ability to work effectively with others and build positive working relationships.
• Self-motivated with a desire to learn and take initiative.
• Some project management skills OR experience of leading small or big projects.
• Desirable to have experience in internal and external audits.