Job Description

itD is seeking a Document Specialist V to support our product programs by managing the full documentation lifecycle from concept through obsolescence. This is a highly collaborative and detail-oriented role that plays a key part in supporting FDA compliance and medical device standards. The ideal candidate will have experience working in a regulated medical device environment and be comfortable operating with minimal supervision in a fast-paced setting.

This long-term W2 opportunity is based onsite in Sunnyvale, CA.

Pay Rate: $95-115 per hour, depending on experience

We provide comprehensive medical benefits, a 401k plan, paid holidays, and more. Please note that we are only considering direct W2 candidates at this time, as we are unable to offer sponsorship.

Responsibilities:

• Support Quality Management System (QMS) documentation and records throughout the product lifecycle.
• Create and release documents based on input from quality and compliance teams to support new product introductions, production product releases, clinical trials, and FDA submissions.
• Ensure documentation and data related to the QMS are controlled for integrity and accessibility.
• Oversee document control activities including document management, version control, distribution, and reporting in accordance with regulatory standards.
• Facilitate compliance through effective cross-functional communication with Operations, Supply Chain, and Engineering teams.
• Maintain all applicable records including validation reports, test reports, and exit reviews as defined by relevant regulations.
• Support audits for licensure and accreditation documents.
• Maintain documents resulting from periodic reviews.
• Manage and organize complex projects and priorities; provide detailed documentation updates to cross-functional teams.
• Support the implementation of new eQMS systems.
• Provide end user support and issue resolution for document control systems.

The internal responsibilities will be as follows:

• Attend regular internal practice community meetings.
• Collaborate with your itD practice team on industry thought leadership.
• Complete client case studies and learning material. (Blogs, media material).
• Build out material to contribute to Digital Transformation practice.
• Attend internal itD networking events (in person and virtual).
• Work with leadership on career fast-track opportunities.

Required qualifications and skills

• 5+ years of experience in a high-tech, fast-paced environment, managing QMS documentation for medical device programs
• Experience working in a regulated medical device environment
• Proficient in document control processes, including versioning, distribution, and audit preparation
• Familiarity with FDA regulations, ISO 13485, and CFR Part 11
• Proficiency in document management tools such as Teamcenter or other PLM systems
• Strong organizational, communication, and problem-solving skills
• Flexible, responsive, and able to handle multiple priorities

Preferred qualifications and skills

• Familiarity with Teamcenter
• Basic knowledge of PLM processes
• Experience supporting new product categories in consumer electronics

Education

• Bachelor’s degree in related field. ​C

ompany descriptionA

bout itD:W

e are part of a new generation of consulting and software development company that blends diversity, innovation, and integrity with real business results. Our structure rejects any strong hierarchy, empowering us to deliver excellent results. We are a woman- and minority-led firm. Every day, we challenge ourselves to be considerate, fair and to re-think what great outcomes mean for our customers. This permeates down to how we approach every interaction, on every project, for every client. You’ll thrive here if you are a dynamic self-starter, a difference-maker or someone who wants to deliver great results, without constraints.

T

he itD Digital Experience:​ J

oining us means you’ll be part of our global community, you have a say about your own career journey, and you’ll get a chance to give back to causes that matter. You will experience working with Fortune 500 companies and high-performance teams across numerous industries. i

tD offers our employees excellent benefits such as medical, dental, vision, life insurance, paid holidays, 401K + matching, networking & career learning and development programs. We are growing and we want to see you grow!​ ​

Visit to learn more about what working at itD can mean for you. A

ll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.

i tD is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a r easonable accommodation for any part of the application process, or to perform the essential functions of a position, please contact us at recruiting@itdtech.com and let us know the nature of your request and your contact information.

A

dditional infoD

ynamic environment in a culture of respect, empowerment and recognition for a job well done, apply today!]]><

Job Tags

Hourly pay, Holiday work, Remote job, Flexible hours,

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