Quality Associate ISO 9001 Experience - Medical Device Factory

Location: Brackley Northamptonshire UK

About Us: Our Client is a pioneering medical device manufacturer dedicated to enhancing patient care through innovative solutions. Committed to upholding the highest standards of quality and compliance. Our Client is looking for a diligent and detailoriented Quality Associate with ISO 9001 experience to join our team.

Bullet Points:

• Minimum of 3 years of experience in quality assurance or a related role within the medical device industry.
• Knowledge of ISO 9001 standards and quality management systems.
• Certification in Quality Management (e.g. ASQ CQE).
• Experience with other quality standards and regulations (e.g. ISO 13485)

Job Description:

Position Overview: The Quality Associate will play a crucial role in supporting the Quality Management System (QMS) to ensure compliance with ISO 9001 standards. This position involves conducting quality assurance activities assisting with audits and maintaining documentation to support our medical device manufacturing operations.

Key Responsibilities:

• Support the implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 9001 standards.
• Assist with internal and external audits including preparation documentation and followup on findings.
• Maintain and manage quality records documentation and reports to ensure accuracy and compliance.
• Conduct quality assurance activities such as inspections testing and calibration.
• Participate in the investigation and resolution of quality issues nonconformances and customer complaints.
• Monitor quality performance metrics and assist in identifying areas for improvement.
• Collaborate with crossfunctional teams including production engineering and R&D to ensure quality standards are upheld.
• Provide support in training staff on quality processes and procedures.
• Contribute to continuous improvement initiatives to enhance product quality and optimize manufacturing processes.
• Stay updated on industry trends regulatory changes and best practices in quality management.

Qualifications:

• Bachelors degree
• Strong organisational and documentation skills.
• Excellent communication and interpersonal abilities.
• Analytical and problemsolving skills.
• Proficiency in quality management software and tools.

Benefits:

• Competitive salary
• Retirement savings plan with company match.
• Opportunities for professional development and career advancement.
• Collaborative and supportive work environment.