United Ortho
Quality Manager
United Ortho, Laotto, Indiana, United States, 46763
Job Summary:
The Quality Manager will oversee and manage global quality assurance and control activities within United Ortho and international entities. This role is responsible for ensuring that products meet all safety, regulatory, and performance standards, while driving continuous improvement initiatives to enhance product quality and operational efficiency.Key Responsibilities:Quality Assurance Management:Develop, implement, and maintain the Quality Management System (QMS) in compliance with regulatory standards (e.g., FDA, ISO 13485 and MDR)Oversee product quality throughout the production process and post-market surveillance.Conduct regular quality audits and inspections to ensure compliance with internal and external standards.Regulatory Compliance:Ensure that all products and processes adhere to applicable regulations and standards (e.g., FDA, CE and MDR marking).Prepare and maintain documentation required for regulatory submissions and audits / inspections.Keep abreast of changes in regulations and standards, and update procedures and policies accordingly.Product Testing and Validation:Coordinate and oversee testing and validation processes for orthopedic braces and supports.Review and approve test plans, protocols, and reports to ensure they meet required specifications (IQ, OQ, and PQ)Investigate and address any product failures or non-conformance issues, implementing corrective and preventive actions as needed (CAPA)Continuous Improvement:Identify opportunities for process improvements and lead initiatives to enhance product quality and efficiency.Implement and monitor key quality metrics and KPIs to drive performance improvements.Foster a culture of quality within the organization through training and development programs.Customer and Supplier Interaction:Address and resolve quality-related issues or complaints from customers in a timely and effective manner.Collaborate with suppliers to ensure that raw materials and components meet quality standards.Conduct supplier audits and assessments to evaluate their quality performance.Documentation and Reporting:Maintain accurate and up-to-date quality documentation, including procedures, work instructions, and records.Prepare and present quality reports and analysis to senior management.Ensure traceability and proper documentation for all quality-related activities.Qualifications:Education:
Bachelor's degree in Engineering, Biomedical, Quality Assurance, or a related field. Advanced degree or certifications (e.g., CQM, CQE, ISO 9001 Lead Auditor, Six Sigma Green Belt) preferred.Experience:
Minimum of 5 years of experience in quality management within Class 1 medical device in orthopedic industry. Successful management of multiple sites in geographically dispersed locations preferred.Knowledge:
Strong understanding of quality management systems, regulatory requirements, and industry standards specific to orthopedic products. ISO 13485 preferred.Skills:
Excellent analytical and problem-solving skills, with attention to detail. Strong communication and leadership abilities. Proficiency in quality management software and tools.Other:
Candidates will be expected to obtain a company-sponsored visa if applicable.Working Conditions:Travel Requirements: International 15%Occasional lifting of up to 50 poundsManeuver around, under, and about factory/laboratory equipment and warehouse pallet storage on a regular and continuous basisApplication Process:Interested candidates should submit their resume and cover letter to Andy Opliger - President
The Quality Manager will oversee and manage global quality assurance and control activities within United Ortho and international entities. This role is responsible for ensuring that products meet all safety, regulatory, and performance standards, while driving continuous improvement initiatives to enhance product quality and operational efficiency.Key Responsibilities:Quality Assurance Management:Develop, implement, and maintain the Quality Management System (QMS) in compliance with regulatory standards (e.g., FDA, ISO 13485 and MDR)Oversee product quality throughout the production process and post-market surveillance.Conduct regular quality audits and inspections to ensure compliance with internal and external standards.Regulatory Compliance:Ensure that all products and processes adhere to applicable regulations and standards (e.g., FDA, CE and MDR marking).Prepare and maintain documentation required for regulatory submissions and audits / inspections.Keep abreast of changes in regulations and standards, and update procedures and policies accordingly.Product Testing and Validation:Coordinate and oversee testing and validation processes for orthopedic braces and supports.Review and approve test plans, protocols, and reports to ensure they meet required specifications (IQ, OQ, and PQ)Investigate and address any product failures or non-conformance issues, implementing corrective and preventive actions as needed (CAPA)Continuous Improvement:Identify opportunities for process improvements and lead initiatives to enhance product quality and efficiency.Implement and monitor key quality metrics and KPIs to drive performance improvements.Foster a culture of quality within the organization through training and development programs.Customer and Supplier Interaction:Address and resolve quality-related issues or complaints from customers in a timely and effective manner.Collaborate with suppliers to ensure that raw materials and components meet quality standards.Conduct supplier audits and assessments to evaluate their quality performance.Documentation and Reporting:Maintain accurate and up-to-date quality documentation, including procedures, work instructions, and records.Prepare and present quality reports and analysis to senior management.Ensure traceability and proper documentation for all quality-related activities.Qualifications:Education:
Bachelor's degree in Engineering, Biomedical, Quality Assurance, or a related field. Advanced degree or certifications (e.g., CQM, CQE, ISO 9001 Lead Auditor, Six Sigma Green Belt) preferred.Experience:
Minimum of 5 years of experience in quality management within Class 1 medical device in orthopedic industry. Successful management of multiple sites in geographically dispersed locations preferred.Knowledge:
Strong understanding of quality management systems, regulatory requirements, and industry standards specific to orthopedic products. ISO 13485 preferred.Skills:
Excellent analytical and problem-solving skills, with attention to detail. Strong communication and leadership abilities. Proficiency in quality management software and tools.Other:
Candidates will be expected to obtain a company-sponsored visa if applicable.Working Conditions:Travel Requirements: International 15%Occasional lifting of up to 50 poundsManeuver around, under, and about factory/laboratory equipment and warehouse pallet storage on a regular and continuous basisApplication Process:Interested candidates should submit their resume and cover letter to Andy Opliger - President