What are the responsibilities and job description for the QA Manager **ISO EXPERIENCE REQUIRED position at I MEDICAL EQUIPMENT & SERVICES?
**ISO EXPERIENCE REQUIRED
Job Description:
As the Quality Manager/Quality Control, you will be responsible for overseeing and implementing quality assurance and control processes across all aspects of our medical equipment repair and service operations. You will ensure compliance with regulatory requirements, maintain quality standards, and drive continuous improvement initiatives to enhance the overall quality of our services. Willing to travel back and forth Indiana/Virginia areas for quarterly trips and audits.
Key Responsibilities:
Develop and implement quality management systems (QMS) to ensure compliance with industry regulations and standards, such as ISO 9001:2015, 13485 and FDA requirements.
Perform and control the full audit cycle including risk management and control management over operations' effectiveness, financial reliability and compliance with all applicable directives and regulations.
Conduct regular audits and inspections of processes, facilities, and documentation to identify areas for improvement and ensure adherence to quality standards.
Collaborate with cross-functional teams, including technicians, engineers, and customer service representatives, to address quality issues and implement corrective and preventive actions.
Determine internal audit scope and develop annual plans.
Obtain, analyze and evaluate accounting documentation, previous reports, data, flowcharts etc.
Prepare and present reports that reflect audit's results and document process.
Act as an objective source of independent advice to ensure validity, legality and goal achievement.
Identify loopholes and recommend risk aversion measures and cost savings.
Maintain open communication with management and auditor.
Document process and prepare audit findings through memorandums.
Conduct follow up audits to monitor management's interventions.
Engage to continuous knowledge development regarding sector's rules, regulations, best practices, tools, techniques and performance standards.
Lead training programs to educate staff on quality policies, procedures, and best practices, fostering a culture of quality and accountability throughout the organization.
Investigate customer complaints and non-conformances and develop effective solutions to prevent recurrence and enhance customer satisfaction.
Monitor key performance indicators (KPIs) related to quality and develop reports to track performance trends and areas for improvement.
Stay abreast of industry trends, regulatory changes, and best practices in quality management for medical equipment repair and service.
