Job Description

We are seeking a detail-oriented and experienced Quality Systems Management Coordinator to join our team. You will be responsible for sustaining and improving the Quality Management System to ensure that our products meet the highest quality standards and comply with all relevant regulations as well as, create, implement, and maintain work instructions based off process flows.

This role requires excellent interpersonal and communications skills, knowledge of quality and safety regulations, and the ability to develop and deliver quality and safety training programs.

Responsibilities:

• Oversee and maintain our Quality Management System, ensuring full compliance with ISO standards (ISO 13485)
• Develop and maintain quality documentation, including standard operating procedures (SOPs) and work instructions in accordance with the standard.
• Manage the Corrective/Preventive Actions process, driving solutions to closure and addressing audit findings and customer issues.
• Schedule, coordinate, and conduct both internal and external audits.
• Maintain Supplier and Customer monthly Scorecards, sending out monthly reports to suppliers shown on the Preferred Supplier list.
• Collaborate with cross-functional teams to maintain, enhance, and implement quality systems and processes.
• Engage with customers and customer service to resolve quality issues, including site visits and communication as required.
• Manage customer returns; lead investigations into non-conformances and customer complaints, identifying root causes and implementing corrective actions.
• Provide training to employees on quality systems, procedures, and best practices.
• Stay up to date with changes to the ISO13485 standard as well as industry best practices.
• Support the development and implementation of continuous improvement initiatives.
• Perform other duties as assigned.

Education/experience:

• A bachelor’s degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline, and at least one year experience in regulatory affairs or quality management system relating to medical devices – OR - our years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
• Experience in conducting ISO or regulatory audits.
• Proficient in technical and report writing, strong verbal and presentation skills, able to effectively liaise with all levels of facility personnel, customers, and suppliers.
• Strong knowledge of quality management principles, practices, and methodologies.
• Familiarity with FDA and EU MDR regulations a plus.
• Experience with an ERP system (SAP) a plus.
• Ability to conduct root cause analysis, analyze data, identify trends, and make data-driven decisions.
• Initiative, independence, and the ability to work effectively with minimal supervision.
• Proficient in project management techniques, including planning, organizing, and monitoring project progress.

Pay : $27.00 - $30.00 per hour

Expected hours: 40 per week.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

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