Quality Coordinator

Job Title: Coordinator, Quality

FLSA: Non-Exempt

Reports To: Quality Department Management

Position Summary: The Quality Coordinator plays a key role in supporting quality assurance activities and projects as directed by the Quality Assurance Manager. This position involves analyzing and investigating to enhance products, processes, and data integrity while ensuring compliance with quality and regulatory standards.

Daily responsibilities:

• Assist with all quality-related activities and projects as directed by the Quality Assurance Manager.
• Analyze and investigate to improve product quality and processes.
• Respond to customer inquiries regarding product specifications and the quality management system.
• Ensure products meet established quality and regulatory standards, including reliability, usability, performance, and safety.
• Collaborate with teams and committees to maintain organizational quality standards.
• Maintain accurate and up-to-date information in the ERP system.
• Collect and organize material and product documentation to support regulatory requirements.
• Review customer specifications for accuracy.
• Create, revise, and release product drawings as needed.
• Assist in coordinating and releasing product Change Notifications.
• Communicate with management to address and resolve issues.
• Recommend and implement improvements to operational methods and practices.
• Investigate customer complaints and non-conformance issues, responding to requests for information as necessary.
• Participate in corrective and preventive actions, including root cause analysis.
• Conduct internal audits of management systems per the audit schedule.
• Support external audits conducted by customers and regulatory bodies.
• Take on additional tasks and projects as assigned by the Quality Assurance Manager.
• Travel: Less than 5%.

Education/Technical Certifications:

• An Associate degree or equivalent work experience is preferred, but candidates with diverse educational and professional backgrounds are encouraged to apply.
• Relevant certifications (e.g., Quality Auditor, Quality Engineer, Quality Improvement Associate, Lean Six Sigma Green Belt) are a plus.

Experience:

• Proven experience in a Quality Assurance or Quality Control department.
• Familiarity with quality management systems and their tools and methods.
• Knowledge of standards such as ISO 13485, ISO 9001, and 21 CFR Parts 820, 210, and 211 is a plus.

Skillsets:

• Understanding medical devices, biotechnology, and cleanroom environments is beneficial.
• Proficient in Microsoft Office, particularly MS Excel.
• Knowledge of manufacturing and validation processes, as well as distribution and environmental systems, is advantageous.
• Strong communication skills for effective collaboration.
• Excellent data collection and analysis abilities.
• High attention to detail and ability to multitask efficiently