Quality Documentation Specialist

We are seeking a highly motivated and detail-oriented Quality Documentation Specialist to join our dynamic manufacturing team. In this pivotal role, you will be responsible for developing, maintaining, and ensuring compliance of all quality documentation in accordance with industry standards and regulatory requirements. Your expertise will help uphold the integrity of our quality management systems, support manufacturing excellence, and drive continuous improvement initiatives. If you thrive in a fast-paced environment and are passionate about quality assurance and meticulous documentation, this is the opportunity for you to make a meaningful impact.

Duties

• Prepare, review, and update quality documentation including procedures, work instructions, inspection reports, and audit records to ensure accuracy and compliance with ISO 13485, ISO 9001, FDA regulations, and other relevant standards.
• Coordinate with cross-functional teams to gather data for quality reports and documentation audits.
• Support internal and external quality audits by providing necessary documentation and facilitating audit processes.
• Maintain comprehensive records of quality inspections, calibration activities, and validation reports using precision measuring instruments such as calipers, micrometers, vision inspection systems, and coordinate measuring machines (CMM).
• Ensure all documentation aligns with regulatory requirements such as CGMP (Current Good Manufacturing Practices), HACCP (Hazard Analysis Critical Control Point), and other applicable standards.
• Assist in the implementation and monitoring of quality systems to ensure consistent adherence to established protocols.
• Conduct data collection activities related to quality control inspections using analysis skills to identify trends or deviations.
• Support calibration schedules for measurement tools including micrometers, calipers, and vision inspection systems to guarantee measurement accuracy.
• Participate in quality audits focusing on QA/QC processes within manufacturing environments to identify areas for improvement.
• Collaborate with manufacturing teams to ensure proper documentation of processes and product specifications are maintained throughout production cycles.
• Contribute to continuous improvement initiatives by analyzing quality data and recommending corrective actions.

Qualifications

• Proven experience in quality documentation within a manufacturing or medical device environment preferred.
• Strong understanding of ISO 13485, ISO 9001 standards, FDA regulations, CGMP practices, HACCP principles, and quality management systems.
• Proficiency with calibration tools such as calipers, micrometers, coordinate measuring machines (CMM), vision inspection systems, and other precision measuring instruments.
• Excellent analysis skills with the ability to interpret data collected from various measurement devices.
• Experience conducting or supporting quality audits and inspections in a regulated environment.
• Familiarity with Calypso software or similar quality management software is advantageous.
• Knowledge of calibration procedures for measurement instruments including micrometers and calipers.
• Strong organizational skills with attention to detail in document control processes.
• Effective communication skills for collaboration across departments and supporting audit activities.
• Ability to work independently while managing multiple priorities efficiently. Join us as a Quality Documentation Specialist to ensure our products meet the highest standards of safety, efficacy, and compliance! Your dedication will directly contribute to delivering exceptional quality products that improve lives worldwide while advancing your career in a thriving industry committed to excellence.

Job Types: Full-time, Part-time

Pay: $31.16 - $37.53 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Work Location: Remote

Salary : $31 - $38