Technical Writer
Job Posting for Technical Writer at Stone Alliance Group
Our client is a top-tier manufacturer of implantable medical devices for the world’s leading medical OEM’s. Driven by innovation and experience spanning three decades, they ensure critical supply chain requirements are met in order to enhance the lives of patients globally. Our client combines cutting-edge technology, innovative solutions, and experienced teams to help bring some of the most important medical devices to market. They bridge the gap between ideas and life-changing devices utilized by surgical teams in every corner of the planet.
SUMMARY OF POSITION
The position is responsible for creating and assisting with engineering documentation, along with training records to ensure smooth transfer of NPI (New Product Introduction) to production. Documentation will be compliant with our client’s Quality Management System (QMS), Specific elements of the QMS may include, but are not limited to:
ESSENTIAL FUNCTIONS:
Duties and responsibilities include, but are not limited to:
QUALIFICATIONS:
Education
SUMMARY OF POSITION
The position is responsible for creating and assisting with engineering documentation, along with training records to ensure smooth transfer of NPI (New Product Introduction) to production. Documentation will be compliant with our client’s Quality Management System (QMS), Specific elements of the QMS may include, but are not limited to:
- Design Change Controls (Engineering Prints/Specifications)
- Quality System Document Change Control (Procedures, WIs, forms; and Templates).
- Internal & External Auditing Documentation Support
- Training and Education
ESSENTIAL FUNCTIONS:
Duties and responsibilities include, but are not limited to:
- Create documented work instructions, based on component processes, through note taking, pictures, observation, and engineering input.
- Update documents when new or existing products or procedures change including new equipment introduction.
- Assist in maintenance, and distribution of documentation for processes of manufacturing.
- Creating tool list documentation, with engineering support.
- Creating set-up documentation, with engineering support.
- Creating post process procedures and documentation with engineering support.
- Assist with Tool data management.
- Create ECO for documentation, procedures, and associated documents along with training records and place into their system.
- Assist in developing the best practice for engineering documentation.
- Ability to work with outside tool vendors to obtain prints or cad files.
- Work with NPI and Sustaining engineers to ensure documentation of processes is up to date and compliant with current practice.
- Ability to manage multiple priorities effectively and independently through completion with high degree of accuracy.
- Other duties and responsibilities as assigned.
QUALIFICATIONS:
Education
- High School Diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
- Bachelor’s degree a plus
- Minimum 5-8 years of experience in a regulated manufacturing environment
- Medical Device or other regulated manufacturing experience (Aerospace, Defense, Pharma., etc.)
- Ability to manage multiple priorities effectively and independently through completion with high degree of accuracy.
- Skilled with problem solving and strong attention to detail.
- Ability to communicate with multiple levels of employees from entry level to executive.
- Strong verbal and written English language communication skills.
- Demonstrate ability and/or experience in computer use and general office software - Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Auto Cad experience a plus.
- Ability to travel if needed to other US Manufacturing sites (10% or less).
- Ability to work with a wide variety of functional areas, including NPI, Engineering, Manufacturing, and QA, as required accomplishing results with minimal guidance.
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Hourly Wage Estimation for Technical Writer in Big Lake, MN
$43.37 to $53.55
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