Title: Document Specialist V

Location: Onsite Sunnyvale, CA

Duration: 12 Months

Summary:

The Document Specialist will support product programs by managing Standard Operating Procedures (SOPs), Work Instructions, Forms, and Records from concept through product obsolescence. This role is ideal for someone experienced in regulated environments (e.g., ISO 13485) who can work independently, with strong attention to detail and an ability to manage competing priorities.

Responsibilities:

• Support the Quality Management System (QMS) documentation and records throughout the product lifecycle
• Create and release documentation in support of new product introductions, production releases, clinical trials, and FDA submissions
• Ensure all Quality System documentation and data are controlled for integrity and accessibility
• Oversee document control functions including version control, distribution, and reporting
• Collaborate with Operations, Supply Chain, and Engineering to maintain compliance with medical device standards
• Maintain essential records including validation/test reports and exit reviews
• Assist with licensure and accreditation audit submissions
• Maintain documents following periodic review cycles
• Manage and organize complex projects, solve documentation release issues, and communicate progress across teams
• Support the implementation of a new electronic Quality Management System (eQMS)
• Provide end-user support and troubleshoot issues

Qualifications:

• 5+ years of experience in document control within a high-tech, fast-paced, or consumer electronics environment
• Hands-on experience supporting Quality Management System documentation in medical device settings
• Familiarity with FDA regulations and ISO 13485 compliance
• Experience with Teamcenter or related PLM/Document Management systems
• Proficiency with Google Suite tools (Docs, Sheets, etc.)
• Understanding of 21 CFR Part 11 compliance

Preferred Skills:

• Experience working within regulated medical device environments
• Familiarity with PLM processes
• Experience supporting documentation for FDA compliance, clinical records, and history files

Education:

• HSD

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at [email protected] if you require reasonable accommodation.

California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting [email protected].

LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.