About the Company Our client is a global leader in the medical devices industry, dedicated to improving lives through innovative healthcare solutions.
With a strong commitment to quality, compliance, and continuous improvement, they strive to deliver the highest standards in product development and manufacturing.
Their team is driven by collaboration, expertise, and a shared mission to enhance patient care worldwide.
Role Overview An exciting opportunity has arisen for a Quality Operations Manager to join a leading medical device manufacturer.
This role is pivotal in ensuring compliance with regulatory standards, driving quality improvements, and leading a high-performing team.
Benefits:
Competitive Salary Performance-
Based Bonus Comprehensive Healthcare Package Relocation Assistance Visa Sponsorship Available Key Responsibilities Quality Leadership:
Act as a key member of the Quality Leadership Team, ensuring compliance with ISO standards and regulatory requirements.
Team Development:
Lead, mentor, and develop the Quality Engineering Team to foster a culture of excellence and continuous improvement.
Process Improvement:
Drive Six Sigma initiatives and collaborate with production teams to enhance efficiency and product quality.
Regulatory Compliance:
Oversee CAPA processes, manage audits, and ensure high-quality documentation to meet industry regulations.
Quality System Management:
Maintain key quality system elements, including non-conformance investigations, incident reporting, and customer complaint handling.
GMP Compliance:
Ensure all production and quality engineering activities adhere to Good Manufacturing Practice (GMP) standards.
Customer Collaboration:
Build and maintain strong relationships with external stakeholders to ensure quality expectations are met.
Requirements A third-level qualification in Engineering or a Science discipline; a postgraduate qualification is an advantage.
Minimum 5+ years experience in an ISO 9001/2000 or ISO 13485 environment, ideally within Medical Devices or Pharmaceuticals.
At least 3 years of supervisory experience with a proven ability to lead and develop teams.
Strong knowledge of Statistical Process Control (SPC) and Six Sigma methodologies (Green Belt certification preferred).
Experience managing CAPA systems, technical documentation, and regulatory audits, including FDA requirements.
Exposure to process validation, sterilization, and cleanroom environments is desirable.
Excellent problem-solving, analytical, and communication skills.
Strong IT proficiency and ability to work in cross-functional teams.
Why Join?
Impactful Work:
Play a crucial role in ensuring the highest quality standards for life-enhancing medical devices.
Collaborative Culture:
Be part of a team that values expertise, innovation, and continuous improvement.
Career Growth:
Benefit from professional development opportunities and leadership training.
Commitment to Excellence:
Join an organization dedicated to delivering industry-leading products and solutions.
Skills:
Operations Quality Manager