What are the responsibilities and job description for the Quality Management System position at Katalyst CRO?
Job Description
- Our client is launching a major initiative to transform its Quality Management System (QMS), and we are seeking a hands-on Quality Technical Lead to perform the technical and operational aspects of this effort.
- This is an individual contributor role with a strong focus on business systems analysis (BSA), process definition, and software testing, not a traditional project manager position.
- This role requires deep eQMS expertise, strong analytical skills, and a proactive approach to problem-solving.
- The ideal candidate will bring a supply chain and manufacturing background, understanding of core quality validation processes, deep experience in medical device and regulatory environments, and the ability to bridge IT and business operations.
- This role will be instrumental in defining and validating processes, gathering requirements, and supporting system testing.
- Lead the technical execution of the QMS transformation project, ensuring it is configured correctly and meets the organization's requirements.
- Define and document process requirements in collaboration with Quality, Manufacturing, and Supply Chain teams.
- Perform software testing and QA validation (non-regulatory) to ensure system functionality and alignment with business needs.
- Act as a technical SME on QMS systems, supporting configuration, testing, and implementation.
- Collaborate with Quality to ensure system capabilities meet operational and compliance requirements.
- Support SEO, manufacturing, and engineering teams in transitioning to new digital quality workflows.
- Drive hands-on execution of testing, validation, and process mapping activities.
- Provide input into future PMO structure and governance as the quality function matures.
- No direct reports (This position will not have management responsibilities).
- Bachelor's degree in information systems or related field.
- 58 years of experience with eQMS systems, including hands-on configuration and support. Familiarity with Master Control a plus.
- Strong experience in Quality Systems, Supply Chain, and Manufacturing within medical device and regulated environments.
- Proven experience in eQMS implementation, with a strong understanding of quality processes and IT interfaces.
- Proven ability to implement technical programs and define business processes.
- Experience with software testing, QA validation, and requirements documentation.
- Understanding of QMS platforms and their integration with IT systems.
- Ability to work independently and drive initiatives as an individual contributor.
- Strong communication and stakeholder engagement skills.
- Program management experience with a technical edge; ability to balance IT and business needs.
- Familiarity with SEO or digital quality tools.
- Change management exposure or training.
