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Senior Manufacturing Engineering Specialist, Documentation

Cook Medical

Cook Medical

Ellettsville, IN, USA
Posted on Thursday, May 30, 2024

Senior Manufacturing Engineering Specialist, Documentation

Requisition ID 2024-14643
Posting Date 5 days ago(5/28/2024 8:21 AM)
Job Location(s)
Ellettsville IN United States
Travel
None
Shift Type
1st shift
Position Type
Full Time
Company
Cook Inc - Ellettsville
Category
Engineering

Overview

The Senior Documentation Specialist will be responsible for ensuring the accuracy, completeness, and compliance of all documentation related to the design, production, and distribution of medical devices. The ideal candidate will have strong attention to detail, excellent organizational skills, and a thorough understanding of industry standards.

Responsibilities

• Independently produce, organize, and maintain documentation or systems associated with Engineering, Operations and Quality assurance.
• Generate, review and approve documents for accuracy, completeness, and compliance with company standards.
• Collaborate with cross-functional teams to develop and maintain quality management system documentation, including standard operating procedures (SOPs),Drawings, Product Specifications, and quality records.
• Run short-term, long-term, and/or system-focused projects, or complete significant tasks critical to projects.
• Maintain high knowledge level related to the team's focus and relevant company systems.
• Work closely with cross-functional teams including Manufacturing, Validation Engineering and Quality Assurance to ensure alignment of Engineering documentation for post-market design and process change activities.
• Provide support and guidance to internal stakeholders on document control procedures and best practices.
• Provide ongoing support and guidance to employees regarding documentation-related inquiries and issues.
• Identify opportunities to streamline documentation processes and improve efficiency while maintaining compliance with regulatory standards.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable.
- Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable.

Qualifications

- AS or BS degree in relevant field; or experience of such kind and amount as to provide a comparable background.
- 2 years experience that relates directly to the above essential job functions/duties.
- Experience working independently and with minimal supervision.
- Working knowledge of Microsoft Office Software (ie: Word, Excel).

Physical Requirements:

• Personal protective equipment including safety glasses, lab coat and gloves required in some areas associated with this position.
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Works under general office environmental conditions.
• Moderate exposure to noise level in the work environment that is moderate to occasionally loud.
• Occasionally lifts and/or moves up to 50 pounds
• Frequently required to stand, walk, use hands to grasp, carry, feel or touch; reach with hands and arms; talk and communicate.

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Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.
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