Our client is looking for a Change Control Quality Specialist to play a pivitol role in managing the change control process within a regulated environemnt, particularly the medical device environment. Must have a bachelor's degree and 3 years of change control experience. Must be bilingual (English and Spanish).

Role Overview:

• Manage and oversee the change control processes to ensure adherence to regulatory compliance and company quality standards.

Key Responsibilities:

• Assess, document, and approve change requests in collaboration with cross-functional teams, including R&D, Manufacturing, and Quality departments.
• Conduct thorough impact assessments on proposed changes, evaluating risks, and developing mitigation strategies.
• Ensure that change control activities are compliant with regulatory requirements, including FDA, ISO, and other relevant standards.
• Maintain and update change control records accurately, supporting audit and inspection preparedness.
• Facilitate regular training sessions for staff on change control procedures and industry best practices.
• Lead cross-functional meetings to align change control activities with broader organizational objectives and project timelines.
• Monitor and report on key metrics for change control processes, providing data-driven insights to stakeholders.
• Contribute to the development and refinement of Standard Operating Procedures (SOPs) and work instructions related to the change control process.
• Support continuous improvement initiatives within the Quality Management System (QMS) by identifying areas for efficiency and effectiveness.

Qualifications:

• Bachelor’s degree in a relevant scientific or technical field.
• Minimum of 3 years of experience in a quality or regulatory compliance role, preferably in a life sciences or medical device industry.
• Strong knowledge of change control processes, regulatory standards (FDA, ISO), and quality management systems.
• Demonstrated ability to work effectively in cross-functional teams and communicate complex information clearly.
• Proficient in data analysis, documentation, and reporting related to change control metrics