Quality Systems Coordinator II M2S, Inc.
M2S, Inc. provides technology and services for the healthcare industry to manage clinical information and utilize it to improve the quality of patient care and reduce costs. Powered by our advanced technological infrastructure and years of experience working in a regulatory environment, M2S is the leader in enterprise healthcare management solutions.
M2S is seeking a Quality Systems Coordinator II. This role will plan, organize, and coordinate quality assurance functions throughout the organization, ensuring they meet the requirements of the overall quality system. The Quality Systems Coordinator interprets and ensures conformance with all applicable regulations and certifications, including GMP, GCP, HIPAA, 21 CFR Part 11, and ISO requirements, to support business objectives. The Quality Systems Coordinator regularly analyzes complex business situations, proposes solutions that will ensure compliance, and implements the solution. Products and services supported by the Quality Systems Coordinator include several healthcare registries which are hosted in the cloud, Class I and II medical devices and associated imaging production services, and imaging core lab operations.
Assisting to assure that the Quality System complies with all regulatory requirements including European MDDs, FDA QSR, GCP, HIPAA, and 21 CFR Part 11.
Ensuring all regulatory reporting is prepared and submitted.
Maintaining an effective audit and surveillance program that demonstrates implementation of required contractual and regulatory requirements within the Company.
Collaborating, advising and teaming with Company management, project teams and other organizations to provide quality solutions in accordance with Company standards and needs.
Assisting department managers in developing quality processes and policies, defining and implementing improvement opportunities, and monitoring performance against established standards and goals.
Establishing, maintaining and implementing communications to increase awareness and improvement of quality issues across the Company.
Ensuring continued communication of performance results to appropriate management personnel, teams and locations.
Ensuring that adequate and appropriate quality tests and checks are in place and conducted for components, in-process and finished products.
Ensuring regulatory compliance for development related to M2S Medical Devices and Components.
Support the regulatory compliance for cloud-based services.
Assisting in implementing new product or service development procedures and documentation.
Assisting with internal and external audits (FDA, Continuing Assessment or surveillance, etc.), generating reports with corrective action plans from these audits and ensuring implementation of corrective actions in a timely fashion.
Conducting internal investigations on customer complaints, where appropriate.
Planning, coordinating, presenting, and tracking Regulatory and ISO training for all affected M2S employees.
Reporting Quality Metrics as needed.
Managing training and controlled documents as required.
Participating in the Corrective and Preventive Action (CAPA) system and organizing and directing regular CAPA team meetings. Determining root causes of quality issues, developing corrective actions and recommendations, and implementing process changes when appropriate.
Assisting in quality control oversight and record approvals when needed.
BA/BS or equivalent experience
A minimum of 3 years? experience in a quality assurance role in a FDA-regulated, ISO-certified company, or HealthCare IT company.
Track record of increased responsibility and demonstrated ability to develop and execute complex projects independently.
Knowledge of FDA Quality System Regulations, SPC, ISO 13485, MDD, HIPAA and computer systems.
Exceptional written and verbal communication skills.
MA/MS or equivalent experience
Lead Auditor certification
Solid knowledge of statistics, data analysis techniques, advanced MS excel user
Six Sigma or Lean certification
We recognize that talented people are attracted to companies that provide competitive pay, comprehensive benefits packages and outstanding advancement opportunities. For this reason we offer a Comprehensive Benefits Plan that includes the following:
401K and Company match
Discount fitness memberships
Flexible spending accounts
Employee life insurance
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