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Job description
QMS & Document Control SpecialistAs a QMS & Document Control Specialist, you will support the effectiveness of the site Quality Management System (QMS) by ensuring controlled documents, change management processes, and training activities are executed accurately and in compliance with regulatory requirements. This role is a key contributor to maintaining an audit-ready state, improving process efficiency, and enabling cross-functional teams to implement changes effectively in a regulated environment.Document Control & QMS SupportExecute document lifecycle processes including creation, review, approval, revision, distribution, and archival in accordance with QMS procedures.Ensure accuracy, completeness, and compliance of controlled documents.Perform periodic document reviews and follow up with document owners.Support maintenance of QMS documentation structure and records.Change Management (ECO/DEV)Administer the Engineering Change Order (ECO) process, ensuring timely processing and compliance.Review ECO submissions for completeness and route for appropriate approvals.Coordinate with cross-functional teams to ensure changes are implemented accurately.Maintain alignment between PLM and ERP systems for approved changes.Systems & Data ManagementServe as a primary user of PLM systems (Agile preferred) for document and part data management.Support data integrity and consistency across systems (PLM, ERP, LMS).Generate routine reports and metrics (e.g., ECO status, overdue documents, training completion).Training CoordinationAssign and track training in the Learning Management System (LMS) for new and revised SOP and Work Instructions.Monitor training completion and follow up on overdue assignments.Audit & Compliance SupportSupport internal and external audits by providing documentation and records.Ensure document control and change records are audit-ready.Continuous ImprovementIdentify process inefficiencies and recommend improvements.Participate in continuous improvement initiatives within document control and QMS processes.CollaborationWork cross-functionally with Engineering, Manufacturing, Quality, and other stakeholders.Provide guidance to document owners and ECO initiators on process requirements.Education: Associate's or Bachelor's degree in Business, Engineering, Life Sciences, or related field preferred, or equivalent experience.Experience, Skills, Abilities:2–5 years of experience in document control, change management, or Quality Systems in a regulated environment.Working knowledge of QMS principles and standards (ISO 9001 and/or ISO 13485 preferred).Experience with PLM systems (Agile preferred) and ERP systems (Intuitive or equivalent), preferred.Strong attention to detail and focus on data accuracy and compliance.Ability to manage multiple tasks and meet deadlines with minimal supervision.Effective written and verbal communication skills.Strong organizational and coordination skills.Ability to follow established processes and identify when to escalate issues.Proficiency in Microsoft Office tools (Word, Excel, Outlook, SharePoint).Physical Requirements / Work Environment:Ability to work in both office and manufacturing environments.Ability to sit and work at a computer for extended periods of time.Ability to occasionally walk the production floor and interact with cross-functional teams.Ability to lift and/or move materials up to 35 lbs with or without reasonable accommodation.EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
Worksite address
santa clara, CA, 95050, US
Who can apply
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