Job Title: QMS Process Lead/SME
Location: Remote
Job Summary: We are seeking a highly experienced professional to lead a critical initiative focused on modernizing quality management systems for a regulated industry client. Our team values strategic thinkers who can bridge business stakeholders and technical implementations, ensuring streamlined and compliant processes.
Responsibilities:
- Lead workshops and interviews with business stakeholders to capture, analyze, and meticulously document current state process requirements, workflows, and pain points for key Quality Management System (QMS) processes.
- Collaborate with cross-functional teams to design, optimize, and document future state processes, aligning them with industry best practices, regulatory requirements, and business objectives.
- Translate business needs into clear and concise functional requirements and user stories for technical configuration and development of the Trackwise Digital platform.
- Review technical design documents, support solution validation and user acceptance testing (UAT), and facilitate the development of SOPs, work instructions, and training materials for a smooth transition.
Required:
- 5+ years’ experience as a Business Analyst or Subject Matter Expert in a Quality Management (QMS) function within a regulated industry (Medical Devices, Pharmaceuticals, or Life Sciences).
- Deep, demonstrable expertise in at least two of the following QMS processes: Non-Conformance (NCEP), Corrective and Preventive Actions (CAPA), and Complaint Handling.
- Proven experience with at least one major system migration or implementation project, possessing strong understanding of mapping “as-is” to “to-be” states.
- Exceptional analytical, communication, facilitation, and documentation skills, with a strong focus on process improvement and stakeholder alignment.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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