+1 866 906 4197
LOCATION: Wilsonville, Oregon
This position will be responsible for administering all documents necessary to define product configuration and control manufacturing processes according to procedures defined in the Company’s Quality System. The Document Control Specialist will ensure that all users have the latest revision of appropriate documentation in a timely manner.
• Perform duties as defined in document control policies and procedures.
• Review change orders for correctness and completeness.
• Provide documentation support, assistance and training to other departments.
• Work on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
• Review documents for accuracy, proper format, and basic Quality/Regulatory compliance (21CFR820/ISO13485)
• Monitor and track the review, approval and distribution of documents to ensure timely completion.
• Work with other departments to ensure uniformity and consistency.
• Identify opportunities for process improvement.
• Maintain company training records.
• Perform administrative duties, as necessary.
• Associates degree or equivalent experience.
• 1-3 years document control experience, preferably in the medical device industry.
• Knowledge of documentation control requirements for medical device manufacturing (21 CFR 820/ISO 13485).
• Experience with electronic documentation management systems preferred.
• Understanding of BoM structure
• Strong knowledge of MS Word, Excel and Outlook is a must.
• Excellent analytical and communication skills, both oral and written.
• Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
• Excellent organizational and prioritization skills.
How We Take Care of Our Own:
AgaMatrix offers competitive compensation packages including medical, dental, disability and life insurance as well as a company match to our 401k Plan.