elkton Work Opportunities ∙ Page 6

Job Summary

The Senior Quality Systems Documentation Specialist will be responsible for developing, managing, and maintaining the documentation necessary for the effective functioning of our quality management system. As a key contributor to our quality system processes, you will collaborate with cross-functional teams to ensure compliance with industry standards and regulatory requirements. Your expertise in quality systems documentation will be vital to driving continuous improvement initiatives and enhancing our overall operational efficiency. This position requires strong analytical skills, attention to detail, and a thorough understanding of quality management principles. You will play a significant role in training team members on documentation standards and methodologies, ensuring that all documentation is not only accurate but also easily accessible for internal audits and external inspections. The ideal candidate will have a proven track record in quality systems documentation, as well as excellent communication skills to convey complex information effectively. The ideal candidate will be passionate about maintaining high standards of quality and can thrive in a fast-paced environment.

Job Responsibilities (continued)

• Quality Data Analysis: Lead the development and maintenance of detailed quality metrics and reports. Analyze data to identify trends that inform continuous improvement initiatives and ensure compliance with regulatory standards.
• Document Control Management: Oversee the document control system, ensuring all documents are up-to-date, easily accessible, and fully compliant with company policies, ISO 13485, and FDA regulations.
• Document Review and Approval: Review, edit, and approve critical documents such as SOPs and work instructions, ensuring alignment with internal policies and external regulatory requirements.
• Documentation Creation: Lead the creation and maintenance of quality process documentation, including standard operating procedures and work instructions, to ensure clear, consistent, and compliant processes.
• Employee Training: Develop and deliver training on quality processes and systems, enhancing team competencies and ensuring compliance with established standards and procedures.
• Quality System Documentation Oversight: Maintain comprehensive quality documentation throughout the product lifecycle, ensuring it aligns with ISO 13485 and FDA regulatory requirements.
• Compliance Monitoring: Monitor and track document revisions and approvals, ensuring continuous adherence to regulatory requirements and internal procedures.
• Audit Support: Provide critical support during internal and external audits, ensuring all documentation is audit-ready and compliant, and assisting with auditor inquiries.
• Cross-Department Collaboration: Coordinate with departments across the organization to ensure accurate and timely documentation of quality events, fostering collaboration and consistency.
• Policy Development: Assist in the creation, revision, and updating of quality policies and procedures, ensuring they meet both regulatory and business needs.
• Product Development Collaboration: Collaborate with product development teams to ensure robust quality documentation is maintained at every stage of the product lifecycle, from development through post-market.
• Training on Documentation Practices: Conduct and lead training sessions on quality system documentation practices, ensuring staff are informed of 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.

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 attention to detail for compliance monitoring and tracking document revisions and approvals.
• Strong knowledge of quality management systems and regulatory standards (e.g., ISO, GMP).
• Proficient in document management software and methodologies.
• Exceptional writing and editing skills with a keen eye for detail.
• Ability to work collaboratively in a team-oriented environment.
• Strong analytical and problem-solving skills with the ability to manage multiple projects simultaneously.

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 5 years of experience in quality systems documentation or related fields.