Document Control Coordinator II

Working Location: MASSACHUSETTS, WESTBOROUGH 

Workplace Flexibility: Hybrid

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

Document Control team member supporting the coordination and processing of Documentation Changes.

Job Duties

• Support all release and change activity for new and existing products, plus all other controlled documents.
• Review all types of Changes(ECOs, COs, IMC s, POR s, PRA s)s and supporting documentation for accuracy, maintaining target turn around times as agreed upon with supervisor.
• Update procedure specification type word documents as required.
• Perform data entry into the PLM & MRP system as required (Including New Catalog & Item numbers, Bills of Materials, Engineering Changes and Deviations).
• Work with Document Control team(all sites) and other departments to support quality and standardization of OSTA documentation process. Promote continuous improvement initiatives(how to improve quality, provide better customer service, reduce costs).
• Partner with Supply Chain Operations Analyst to project manage OSTA POR requirements.
• Schedule and chair meetings on POR progress, publish status reports on the process.
• Work with all departments involved to resolve issues. Thorough documentation of the issues and the resolutions are required.
• Create POR COs and release to Site Doc Control for processing, after receiving an approved POR, within the established time target.
• Train employees new to the POR process as required to meet OSTA business requirements.
• Provide cross functional support to meet business needs as required.
• When Technical Editing needs assistance, provide short term support when Doc Control workload will allow.
• Function as ERP, MRP, PLM expert.
• Provide user support on Agile and Oracle; provide training as required.
• Provide OSTA employee support on meeting Good Documentation Practices based on OSTA QSR documents, ISO 13485, FDA 21 CFR 820.
• Meet deliverable, support and quality targets as established during yearly PED objectives.

Job Qualifications

Required:

• High school diploma or equivalent is required.
• Minimum of 3 to 5 years related Document Control experience in a manufacturing environment.
• Understanding of Quality Change Management Process.
• FDA and ISO experience.
• Experience with MRP ERP PLM Systems.

 

Preferred:

• Drafting, Configuration Management training or certifications are preferred.
• Excellent writing and communication skills. Ability to read, understand and apply information from published process documents.
• Strong office skills: MS office: Word, Excel, Access; data entry, scanning documents, filing.