Job SummaryThe Quality Systems Specialist supports and maintains the Quality Management System (QMS) and oversees the creation, review, approval, revision, and controlled release of quality and technical product documentation including, but not limited to, validation guides, assembly component summaries, component attributes, specifications, validation and compliance documentation, certificates, and related quality records.
The position works cross-functionally with internal teams including Quality, Engineering, R&D/NPI, Regulatory Compliance, Manufacturing, and Supply Chain, as well as external suppliers and customers, to ensure product information is accurate, complete, traceable, and compliant with established quality requirements.
Essential Functions- Develop, compile, review, approve, revise, and maintain controlled quality and technical documentation, including SOPs, specifications, forms, validation guides, and related records.
- Coordinate the collection and verification of product and component information, including drawings, part numbers, materials, suppliers, manufacturers, compliance information, validation data, sterilization information, shelf life, and storage conditions.
- Ensure documentation accurately reflects approved product configurations and is consistent with drawings, specifications, supplier information, and quality records.
- Maintain document revision history, traceability, templates, workflows, and controlled release processes.
- Identify and resolve missing, outdated, inconsistent, or conflicting information with appropriate functional owners.
- Oversee product-specific technical documentation packages supporting customer evaluation, qualification, and validation.
- Coordinate supporting documentation such as component attributes, raw material and manufacturer specifications, validation guides, assembly drawings, Certificates of Conformance, sterilization certificates, and applicable compliance documentation.
- Maintain applicable material, biocompatibility, extractables, regulatory, and sterilization information and ensure information is traceable to the appropriate component and product configuration.
- Support nonconformance investigations, root cause analysis, CAPA, quality improvement activities, and effectiveness verification.
- Assist with internal and supplier audits and support supplier qualification activities.
- Monitor quality information and trends and identify opportunities to improve QMS and documentation processes.
- Support customer and external audits by providing accurate, current, and controlled quality and technical documentation.
- Evaluate changes to products, components, materials, suppliers, specifications, drawings, and validation documentation for impact on controlled documents.
- Coordinate updates to affected validation guides, assembly component summaries, specifications, and supporting records.
- Ensure obsolete information is appropriately controlled and revised documentation reflects the approved product configuration.
- Support product transfers, validation activities, and other quality projects throughout the product lifecycle.
- Respond to customer requests for quality, technical, compliance, and validation documentation, including surveys and questionnaires.
- Coordinate with Engineering, R&D/NPI, Regulatory Compliance, Operations, Manufacturing, Supply Chain, Quality, suppliers, and customers to obtain and verify information.
- Track documentation activities, action items, timelines, risks, and outstanding requirements, and quality processes.
- Perform other tasks as assigned.
Education/Certifications- Bachelor's degree in biological sciences, engineering, or a related technical field.
Required Experience & Competencies- 3+ years' experience in quality systems, quality documentation, technical documentation, or quality management in a regulated manufacturing environment.
- Experience with risk management tools (FMEA) and CAPA/root cause methodologies.
- Working knowledge of QMS principles and document-control practices.
- Experience developing, reviewing, maintaining, and implementing controlled documents.
- Experience coordinating technical information from multiple internal and external sources.
- Experience with nonconformance, CAPA, investigations, audits, supplier qualification, or quality improvement activities.
- Ability to understand and review product drawings, specifications, component information, and validation documentation.
- Strong attention to detail, organization, analytical, and problem-solving skills.
- Ability to identify incomplete, inconsistent, or conflicting technical information and coordinate resolution.
- Strong written and verbal communication skills with the ability to prepare clear, accurate technical documentation.
- Familiarity with biocompatibility, extractables, sterilization, and regulatory compliance documentation.
- Experience with supplier technical documentation and qualification programs.
