Compliance Quality Specialist

RESPONSIBILITES:

· Ensures site quality and compliance systems follow regulatory requirements are operational, support manufacturing, are communicated and understood across the organization.

· Manage the Audit Program, to include internal audits, customer audits, supplier audits, third party certification audits, and others, as necessary. Collaborate with team members, management, and/or customers to establish the annual audit schedule, determine and assign SMEs to audits, establish audit content, allocate time, and schedule meetings. Execute and document audits considering scope to assure efficient and effective use of scheduled time allocations.

· Manage the Corrective Action/Preventive Action Request (CAPA) system and hold regular meetings to discuss them oversee the timely completion of all Root Cause and Corrective Actions, interfacing with internal and external customers whenever needed. Evaluate the effectiveness of corrective actions.

· Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required. Demonstrated knowledge/application of all quality system elements.

· Ability to identify Compliance Risks within responsible areas.

· Manage areas of responsibility to ensure planning objectives are met. Interact with manufacturing management to provide quality perspective on routine operations and support systems.

· Support compliance reporting and provide input to Quality Management Review. Perform trending of data and quality systems as relates to Audit metrics, CAPA metrics and other trending, as required.

· Exhibit Leadership principals, leading Staff to the expectations and Guidelines of Raumedic.

· High degree of computer literacy including excellent written and oral communications skills preferred

· Six Sigma, Process Improvement, and/or Flow Mapping experience preferred

· Responsibility for strict observance of legal rules and regulations referring to work safety and adherence of working time.

Important Particular Tasks:

· Responsible for enforcing Audit program and CAPA program activities to ensure audit-readiness of the Raumedic Mills River site. Ensure CAPA Effectiveness checks are performed and documented to demonstrate suitability of improvement actions.

· Schedule and perform timely CAPA Effectiveness Check activities and ensure timely closure and documentation to meet requirements of regulations, ISO 13485 and Raumedic procedures.

· Assist in generating metrics for overall auditing system and identify continuous improvement opportunities. Develop audit process findings and input to improve process flow for compliance.

· Provide training, guidance, and coaching to team members

· Support and conduct training activities to develop staff awareness and compliance to requirements.

· Provide input and support to develop, review, initiate and update new processes, and risk analyses.

· Prepare and manage updates to Site Quality System Procedures

· Additional duties as required

Job Type: Full-time

Pay: From $105,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• AD&D insurance
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Associate (Preferred)

Experience:

• Document management: 2 years (Required)
• audit: 3 years (Required)
• Regulatory affairs: 3 years (Required)
• FDA regulations: 5 years (Required)

Ability to Relocate:

• Mills River, NC 28759: Relocate before starting work (Required)

Work Location: In person