Quality Director
2 weeks ago
Cork Medical is seeking a highly skilled and experienced Director of Quality and Regulatory Affairs to lead the company's quality management system and regulatory affairs functions.
The successful candidate will be responsible for driving all certifications and registrations, including ISO 13485:2016, MDSAP, 510K, and CE Mark. They will also manage quality procedures and supporting documentation, own the document management system, and provide recommendations for continuous improvement.
The Director of Quality and Regulatory Affairs will audit all quality procedures and supporting documentation, as well as all departments, to ensure the quality management system is being implemented appropriately. They will also manage and own the corrective and preventative action system, support 5S and process improvement, and oversee IQ, OQ, and PQ activities.
Additionally, the Director of Quality and Regulatory Affairs will manage regulatory updates, renewals, registrations, submissions, and 510Ks, as well as maintain and update the PDAC system. They will also be responsible for submission of all paperwork and/or documentation to government bodies or appropriate entities that regulate medical devices and/or the companies that Cork Medical currently engages with or will engage with in the sale and/or distribution of its products or labeled products.
The ideal candidate will have a Bachelor's degree or higher, degree or certification in quality systems or industry-relevant experience, knowledge and experience in technical writing and government submissions, project management experience, and knowledge of computer systems, document management software, or similar.
Key competencies for this role include time management, disciplined approach to process and procedure, self-driven with excellent follow-through, analytical skills, personal effectiveness in a team setting, effective communication, goal-oriented and metric-driven, and ethics with respect for others, inspiring trust, integrity in work, and upholding organizational values and culture.
-
Quality Management Director
2 weeks ago
Marquand, Missouri, United States Acadia Healthcare Full timeJob SummaryWe are seeking a highly skilled Quality Management Director to join our team at Acadia Healthcare. As a key member of our leadership team, you will be responsible for ensuring the highest standards of quality in our facilities.Key ResponsibilitiesMonitor and analyze quality management data to identify areas for improvement and develop strategies...
-
Quality Management Director
2 weeks ago
Marquand, Missouri, United States Acadia Healthcare Full timeJob SummaryWe are seeking a highly skilled Quality Management Director to join our team at Acadia Healthcare. The successful candidate will be responsible for monitoring and analyzing QM data, submitting data to external agencies, and ensuring facility compliance with policies and applicable standards.Key ResponsibilitiesMonitor and analyze QM data for...
-
Director of Quality and Regulatory Affairs
3 weeks ago
Marquand, Missouri, United States Cork Medical Full timeDirector of Quality and Regulatory AffairsCork Medical is seeking a highly skilled and experienced Director of Quality and Regulatory Affairs to join our team. This is a critical role that requires a strong understanding of quality management systems, regulatory requirements, and industry best practices.Key Responsibilities:Drive all certifications and...
-
Associate Director of Quality Initiatives
3 weeks ago
Marquand, Missouri, United States Indiana Afterschool Network Full timeJob Title: Associate Director of Quality InitiativesAt Indiana Afterschool Network, we are seeking a highly skilled and experienced Associate Director of Quality Initiatives to join our team. This role is responsible for executing our access and quality strategies, coaching out-of-school time professionals, and ensuring that providers across the state have...
-
Director of Quality Systems Excellence
6 days ago
Marquand, Missouri, United States Client Staffing Solutions Full timeWe are Client Staffing Solutions, a leading provider of innovative staffing solutions, and we are seeking a highly skilled Director of Quality Systems Excellence to join our team. Our company is committed to delivering exceptional quality standards, and we are looking for a professional who can help us drive quality excellence in our organization. Job...
-
Director of Quality and Regulatory Affairs
4 weeks ago
Marquand, Missouri, United States Cork Medical Full timeJob Title: Director of Quality and Regulatory AffairsCork Medical is seeking a highly skilled and experienced Director of Quality and Regulatory Affairs to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and regulatory compliance across all aspects of our business.Key...
-
Director of Quality and Regulatory Affairs
1 month ago
Marquand, Missouri, United States Cork Medical Full timeJob Title: Director of Quality and Regulatory AffairsCork Medical is seeking a highly skilled and experienced Director of Quality and Regulatory Affairs to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and regulatory compliance across all aspects of our business.Key...
-
Director of Quality and Regulatory Affairs
2 weeks ago
Marquand, Missouri, United States Cork Medical Full timeJob Title: Director of Quality and Regulatory AffairsCork Medical is seeking a highly skilled and experienced Director of Quality and Regulatory Affairs to join our team. As a key member of our Engineering/Quality department, you will be responsible for driving all quality certifications and registrations, including ISO 13485:2016, MDSAP, and 510K.Key...
-
Director of Quality and Regulatory Affairs
2 weeks ago
Marquand, Missouri, United States Cork Medical Full timeJob Title: Director of Quality and Regulatory AffairsCork Medical is seeking a highly skilled Director of Quality and Regulatory Affairs to join our team. The successful candidate will be responsible for owning, auditing, and driving improvements within our Quality Management System (QMS).Main Responsibilities:Drive all Cork Medical certifications &...
-
Associate Director of Quality Initiatives
7 days ago
Marquand, Missouri, United States Indiana Afterschool Network Full timeAbout the RoleThe Associate Director of Quality Initiatives is a key member of the Indiana Afterschool Network team, responsible for executing the organization's access and quality strategies. This role involves coaching out-of-school time professionals, ensuring providers across the state have the knowledge, tools, and resources to implement quality...
-
Associate Director
2 weeks ago
Marquand, Missouri, United States BioSpace, Inc. Full timeJob DetailsLilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. Our employees work together to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We're...
-
Associate Director of Quality Initiatives
2 weeks ago
Marquand, Missouri, United States Indiana Afterschool Network Full timeAbout the RoleThe Associate Director of Quality Initiatives is a key member of the Indiana Afterschool Network team, responsible for executing the organization's access and quality strategies. This role requires a strong background in youth development, curriculum, training, relationship management, and project implementation.Key ResponsibilitiesSupport the...
-
Associate Director
3 weeks ago
Marquand, Missouri, United States Eli Lilly Full timeAbout the RoleWe are seeking an experienced Associate Director to lead our Medicines Quality Organization (MQO) - Safety team. As a key member of our quality leadership team, you will be responsible for ensuring the quality system compliance and quality improvement of the functions you support.Key ResponsibilitiesLead quality system implementation and...
-
Associate Director
2 weeks ago
Marquand, Missouri, United States BioSpace, Inc. Full timeJob SummaryWe are seeking an experienced Associate Director to lead our Medicines Quality Organization (MQO) - Safety team. The successful candidate will be responsible for ensuring quality system compliance and quality improvement of the functions they support.Key ResponsibilitiesLead quality system implementation and continuous improvementManage quality...
-
Senior Director of Quality Control Microbiology
2 weeks ago
Marquand, Missouri, United States Eli Lilly Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director of Quality Control Microbiology to lead our Quality Control Microbiology team at Eli Lilly. The successful candidate will be responsible for overseeing the development and implementation of quality control microbiology strategies, ensuring compliance with regulatory requirements, and...
-
Associate Director, Global Quality Systems
1 week ago
Marquand, Missouri, United States Eli Lilly Full timeJob SummaryWe are seeking a highly experienced and skilled professional to lead our Global Quality Systems team. As Associate Director, Global Quality Systems, you will be responsible for providing strategic leadership and direction to the design, maintenance, and implementation of integrated global quality systems that support Research and Development (R&D)...
-
Quality Assurance Director
2 weeks ago
Marquand, Missouri, United States Aegis Worldwide Full timeQuality ManagerAegis Worldwide is seeking a seasoned Quality Manager to join their team in Indianapolis, IN. This is a direct hire opportunity with a Monday-Friday schedule from 7am-4pm.The ideal candidate will have 5+ years of experience in a Quality Manager role within the manufacturing industry, with a strong background in quality assurance programs,...
-
Senior Director of Quality Control Microbiology
2 weeks ago
Marquand, Missouri, United States BioSpace, Inc. Full timeJob DetailsLilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We are headquartered in Indianapolis, Indiana, and our employees work together to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Quality Management Director
2 weeks ago
Marquand, Missouri, United States Acadia Healthcare Full timeKey Responsibilities: Monitor and analyze quality management data to ensure compliance with regulatory and accrediting bodies. Develop and implement quality plans to improve patient care and safety. Conduct root cause analyses and investigations into serious and sentinel events. Provide staff management and development to ensure effective department...
-
Operations Director
4 weeks ago
Marquand, Missouri, United States Quality Suites Fishers Full timeOperations Manager Job DescriptionAt Quality Suites Fishers, we are seeking a highly skilled and experienced Operations Manager to join our team. As an Operations Manager, you will play a critical role in ensuring the smooth operation of our hotel, providing exceptional guest experiences, and driving business results.Key Responsibilities:Assist the General...