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Essential Functions
Generates, maintains, and updates protocols, technical reports, test methods, manufacturing instructions, project planning documents, and labeling documents.
Creates and maintains design history files and manufacturing BOMs, routers and labels.
Creates memos, marketing documents, instructions for use (IFUs), and labels according to the Quality System.
Collaborates with Research & Development and project management to determine project action items, documentation, and meeting schedules to support product launches.
Prepares project-related documentation such as project plans; utilizes D365 or similar platforms to create part lists, etc.
Creates, maintains, and updates procedures.
Assists in the preparation of technical manuscripts, white papers, and patent documentation. Works closely with R&D teams to ensure clarity, accuracy, and alignment with publication and intellectual property requirements.
Collaborates with engineers, scientists, regulatory and quality staff in the company to ensure accuracy and completeness of all documentation.
Supports internal regulatory requirements related to documentation on assigned projects.
Ensures all testing procedures and documentation comply with ISO, ASTM and other applicable standards.
Provides documentation in support of internal and external audits, and knowledge transfer activities.
Performs other related duties and projects as business needs require at direction of management.
Minimum Qualifications
Associate's degree in a scientific or engineering field with a minimum of four (4) years of technical documentation experience; or Bachelor's degree in a scientific or engineering field with a minimum of two (2) years of technical documentation experience.
Experience in working in dental or medical device industry as a technical writer.
Experience with the use of electronic document control systems such as ETQ or CatsWeb, a plus.
Knowledge of 21 Code of Federal Regulations (CFR) 820 a plus.
Experience working in a Food & Drug Administration (FDA) regulated industry, a plus.
Experience with industry standards such as ASTM, ANSI and ISO a plus.
Pay range: $30.44-$40.58/hr
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.
Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting‑edge technology. We work in a fast‑paced and highly sought‑after employee‑friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let’s talk about a rewarding career at Glidewell!
In addition, we offer generous employee benefits including medical, dental, vision, 401(k) with company match, company‑paid life insurance, on‑site dental services, vacation, holiday, sick time, employee gym, wellness center, cafes, and more.
Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hiring@glidewell.com. Please indicate the specifics of the assistance needed.
Please apply through Employee Transfer Application to complete the transfer request form.
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Essential Functions
Generates, maintains, and updates protocols, technical reports, test methods, manufacturing instructions, project planning documents, and labeling documents.
Creates and maintains design history files and manufacturing BOMs, routers and labels.
Creates memos, marketing documents, instructions for use (IFUs), and labels according to the Quality System.
Collaborates with Research & Development and project management to determine project action items, documentation, and meeting schedules to support product launches.
Prepares project-related documentation such as project plans; utilizes D365 or similar platforms to create part lists, etc.
Creates, maintains, and updates procedures.
Assists in the preparation of technical manuscripts, white papers, and patent documentation. Works closely with R&D teams to ensure clarity, accuracy, and alignment with publication and intellectual property requirements.
Collaborates with engineers, scientists, regulatory and quality staff in the company to ensure accuracy and completeness of all documentation.
Supports internal regulatory requirements related to documentation on assigned projects.
Ensures all testing procedures and documentation comply with ISO, ASTM and other applicable standards.
Provides documentation in support of internal and external audits, and knowledge transfer activities.
Performs other related duties and projects as business needs require at direction of management.
Minimum Qualifications
Associate's degree in a scientific or engineering field with a minimum of four (4) years of technical documentation experience; or Bachelor's degree in a scientific or engineering field with a minimum of two (2) years of technical documentation experience.
Experience in working in dental or medical device industry as a technical writer.
Experience with the use of electronic document control systems such as ETQ or CatsWeb, a plus.
Knowledge of 21 Code of Federal Regulations (CFR) 820 a plus.
Experience working in a Food & Drug Administration (FDA) regulated industry, a plus.
Experience with industry standards such as ASTM, ANSI and ISO a plus.
Pay range: $30.44-$40.58/hr
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.
Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting‑edge technology. We work in a fast‑paced and highly sought‑after employee‑friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let’s talk about a rewarding career at Glidewell!
In addition, we offer generous employee benefits including medical, dental, vision, 401(k) with company match, company‑paid life insurance, on‑site dental services, vacation, holiday, sick time, employee gym, wellness center, cafes, and more.
Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hiring@glidewell.com. Please indicate the specifics of the assistance needed.
Please apply through Employee Transfer Application to complete the transfer request form.
#J-18808-Ljbffr