Quality Specialist

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CP Life Sciences is seeking a skilled and experienced Quality Specialist to oversee quality activities related to medical device products, focusing on IVD kits, procedure packs, and medical devices. The role involves ensuring setup and ongoing compliance with ISO 13485 and relevant standards and regulations.

Duties and Responsibilities

Quality Management System

• Develop, implement, and maintain the QMS according to applicable standards and regulations.
• Ensure continuous improvement of the QMS, processes, and procedures, adopting best practices.
• Participate in and contribute to external audits as an auditee and team member.

Verification & Validation

• Oversee validation processes for systems, equipment, and processes.
• Plan, execute, and analyze verification and validation activities for products, packaging, and manufacturing equipment.
• Record test failures and deviations.
• Identify V&V needs, gaps, and opportunities within the business.
• Engage with stakeholders such as Engineering and Regulatory Affairs.
• Communicate promptly with Quality and Functional leaders.
• Initiate improvements to the V&V process.
• Conduct risk assessments and FMEAs to manage risks and develop mitigation strategies.
• Oversee the risk management process and communicate residual risks.
• Review and assess suppliers, perform audits, and manage supplier performance and risk ratings. Issue SCARs as needed.
• Collaborate cross-functionally on supplier management processes.

Audit Management

• Perform internal audits to ensure compliance with ISO 13485 and other standards.
• Manage external assessments and audits, addressing non-conformances.

Competency Requirements

• Strong communication and interpersonal skills.
• Authority to reject non-compliant products and documentation.
• Promote a quality-focused culture and mindset.
• Integrity, trustworthiness, and reliability.
• Effective time management and prioritization skills.
• Flexibility and adaptability to a growing business.
• Attention to detail with a holistic view.
• Calmness and positivity under pressure, with a focus on continuous improvement.
• Self-motivation and team support skills.
• Excellent verbal and written communication skills.
• Proficiency in MS Office and Outlook; experience with eQMS/ERP/PLM systems is preferred.
• Compliance with company procedures on quality, environmental, health, and safety standards.

For more information, please send your updated CV or contact us at (emailprotected).

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