Document Control Specialist (ISO 13485 and Windchill experience)
Budget / SalaryHourly project
TypeFreelance project
LocationRemote
Posted2 hours ago
Triple Ring Technologies is seeking for a detail-driven Document Control Specialist to administer and safeguard our controlled documentation within our electronic document management system (PTC Windchill). In this role you are the backbone of our Quality Management System (QMS): you make sure every controlled document and record is processed, reviewed, approved, and archived in line with approved procedures and QMS timelines. You will also coordinate the company's QMS-related training program, giving you broad visibility across quality operations and regular collaboration with teams throughout the company.
If you take pride in accuracy, thrive on well-run processes, and want your work to directly support the delivery of safe, compliant medical technologies, we'd love to hear from you.
What You'll Do:
• Coordinate controlled documentation company-wide, serving as the go-to point of contact for document control.
• Facilitate the review, approval, and archival of the company's controlled documentation, keeping every stage moving on schedule.
• Perform the document control function using PTC Windchill / PDMLink, adhering to strict timelines for review and approval processes.
• Support users with document control system needs and document requests, making the process easy for the rest of the organization.
• Support internal and external audits: retrieve required documents and ensure timely, accurate responses to auditor requests.
• Compile timely, accurate data for custom status reports and corporate activities such as quarterly QMS Management Review meetings.
• Assist with quality and training records for the QMS, and coordinate the company's QMS-related training program.
• Support supplier certification, QMS releases, lab notebook distribution and archival, calibration notifications, and additional QA projects as assigned.
• Serve as the point person for monitoring external standards and coordinating orders for new or updated standards.
What You'll Bring
• Bachelor's degree and/or equivalent experience.
• Minimum of 5 years of document control experience, preferably in the medical device industry.
• Sound understanding of the document life cycle within a controlled document management system.
• Working knowledge of FDA requirements, ISO standards, technical nomenclature, quality functions, audits, and CAPA.
• Working knowledge of PTC Windchill / PDMLink (required).
• Sound judgment within broadly defined practices and policies, with strong problem-solving and decision-making skills.
• A systems-oriented mindset; experience with a variety of IT systems is a plus.
• Strong verbal and written communication skills and a collaborative, team-first approach.
If you take pride in accuracy, thrive on well-run processes, and want your work to directly support the delivery of safe, compliant medical technologies, we'd love to hear from you.
What You'll Do:
• Coordinate controlled documentation company-wide, serving as the go-to point of contact for document control.
• Facilitate the review, approval, and archival of the company's controlled documentation, keeping every stage moving on schedule.
• Perform the document control function using PTC Windchill / PDMLink, adhering to strict timelines for review and approval processes.
• Support users with document control system needs and document requests, making the process easy for the rest of the organization.
• Support internal and external audits: retrieve required documents and ensure timely, accurate responses to auditor requests.
• Compile timely, accurate data for custom status reports and corporate activities such as quarterly QMS Management Review meetings.
• Assist with quality and training records for the QMS, and coordinate the company's QMS-related training program.
• Support supplier certification, QMS releases, lab notebook distribution and archival, calibration notifications, and additional QA projects as assigned.
• Serve as the point person for monitoring external standards and coordinating orders for new or updated standards.
What You'll Bring
• Bachelor's degree and/or equivalent experience.
• Minimum of 5 years of document control experience, preferably in the medical device industry.
• Sound understanding of the document life cycle within a controlled document management system.
• Working knowledge of FDA requirements, ISO standards, technical nomenclature, quality functions, audits, and CAPA.
• Working knowledge of PTC Windchill / PDMLink (required).
• Sound judgment within broadly defined practices and policies, with strong problem-solving and decision-making skills.
• A systems-oriented mindset; experience with a variety of IT systems is a plus.
• Strong verbal and written communication skills and a collaborative, team-first approach.
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