Quality Systems Documentation Specialist

Job Summary

The Quality Systems Documentation Specialist plays a critical part in ensuring that our quality management systems meet industry standards and regulatory requirements. This role is responsible for developing, maintaining, and controlling quality system documentation, ensuring consistency and compliance across various departments. The ideal candidate will have a deep understanding of quality assurance principles, documentation control, and regulatory compliance. You will collaborate with cross-functional teams to facilitate projects that enhance quality outcomes and improve operational efficiency. Your ability to analyze current processes, identify gaps in documentation, and recommend corrective actions will be key to your success. This position offers an exciting opportunity to contribute to the continuous improvement of our quality systems, ultimately impacting the safety and effectiveness of our medical devices. The ideal candidate will be passionate about quality and thrive in a dynamic environment.

Job Details/Responsibilities

• Analyze Quality Data: Develop and maintain comprehensive metrics and reports to identify trends that drive continuous improvement and ensure compliance with regulatory standards.
• Document Control Management: Manage and maintain the document control system to ensure all documents are current, accessible, and compliant with company policies and regulatory requirements.
• Document Review and Approval: Review, edit, and approve documents, including SOPs and work instructions, to ensure compliance with internal policies and external regulations (ISO 13485 and FDA).
• Documentation Creation: Create and maintain documentation related to quality processes, such as standard operating procedures and work instructions.
• Employee Training: Train employees on quality processes and participate in the development and execution of quality training programs to enhance team competencies and expertise.
• Quality System Documentation: Develop and maintain quality documentation in alignment with ISO 13485 and FDA regulations, ensuring compliance throughout the product lifecycle.
• Compliance Monitoring: Monitor and track document revisions, approvals, and updates to maintain compliance with established procedures and standards.
• Audit Support: Assist in preparing documentation for internal and external audits, providing necessary information to auditors.
• Cross-Department Collaboration: Coordinate with various departments to ensure accurate and timely documentation of quality events.
• Policy Development: Assist in the creation, revision, and update of quality policies and procedures as necessary to meet regulatory and business needs.
• Collaboration with Product Development: Work with product development teams to ensure proper quality documentation is maintained throughout the product lifecycle.
• Training on Documentation Practices: Conduct training sessions for staff on quality system documentation practices and any changes in procedures or regulations
•   Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large. 
• Other: Perform other job-related duties as assigned. 
   

Knowledge, Skills and Abilities (KSA)

Knowledge:

• Deep understanding of quality assurance principles and documentation control.
• Strong knowledge of regulatory compliance standards, particularly ISO 13485 and FDA regulations.
• Familiarity with audit processes and regulatory requirements within the medical device industry.
• Proficiency in document management systems and quality management software.

Skills:

• Proficient in analyzing quality data, developing reports, and identifying trends for continuous improvement.
• Expertise in document control management, including reviewing, editing, and approving quality documents (SOPs, work instructions).
• Strong collaboration skills to work with cross-functional teams, including product development, to ensure compliance.
• Excellent communication skills for training employees on quality processes and documentation practices.
• Ability to develop and maintain comprehensive quality system documentation.
• Strong knowledge of ISO 13485, FDA regulations, and quality assurance principles.
• Strong attention to detail for compliance monitoring and tracking document revisions and approvals.

Abilities:

• Capable of identifying gaps in documentation and recommending corrective actions.
• Ability to develop, revise, and update policies in alignment with regulatory and business needs.
• Skilled in preparing documentation for internal and external audits.
• Adept at managing cross-department collaboration to ensure timely and accurate documentation.
• Ability to effectively train staff on quality system documentation and procedure changes.

Overall, the role requires a candidate who can blend technical knowledge with strong organizational and communication skills, ensuring that quality systems are compliant and efficiently managed.
 

Qualifications/ Background Experiences

• Bachelor's degree in a relevant field such as life sciences, engineering, or quality management.
• Minimum of 3 years of experience in quality systems documentation within the medical device industry.