Document Control Specialist

Medical Device Components LLC; San Diego (CA); On-site; USD 85,962,000 - 114,616,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid time off and holidays

Job summary

Lighteum is seeking a Document Control Specialist for its San Diego facility. The role focuses on administering the QMS documentation in line with ISO 9001/13485 and regulatory requirements.

You will support cross-functional teams, manage document lifecycle in MasterControl, and ensure compliance across product documentation and quality records.

Qualifications

• High School diploma or equivalent.
• Associate's or bachelor's degree in Engineering, Business Administration, Life Sciences, or related field.
• Minimum of 2 years document control or quality systems experience.
• Experience with ISO 13485 Quality Management System.
• Experience in medical device manufacturing or components.
• Experience with MasterControl or similar eQMS.

Responsibilities

• Administer and maintain controlled documents in MasterControl across sites.
• Manage user access, workflows, templates, and document lifecycle.
• Ensure electronic signatures comply with 21 CFR Part 11.
• Maintain document integrity, traceability, and version control.
• Process document changes including creation, revision, review, and obsolescence.
• Coordinate ECOs and quality system change requests.
• Ensure compliance with ISO 9001/13485 and internal procedures.
• Support audits with controlled documentation and quality records.
• Monitor document control metrics and training status.
• Assist with training and document retention policies.

Skills

Strong written and verbal skills

Ability to manage multiple document变化

Detail oriented

Collaborative teamwork

Quality system awareness

Education

Associate's or bachelor's degree in Engineering, Business Administration, Life Sciences

High School diploma or equivalent

Tools

MasterControl

eQMS systems

Job description

At Lighteum, we pride ourselves on being more than just a place of work. We are a vibrant, innovative team committed to making a difference in the world of medical device components by enhancing the lives of patients worldwide by delivering innovative, high-quality medical components to the MedTech industry.

Be a part of a team dedicated to playing a role in creating solutions that make a real impact. Your work will contribute to improving lives.

We offer a comprehensive benefits package designed to support our associates' well-being. Our health and wellness benefits feature comprehensive medical, dental, and vision insurance. To promote financial security, we also provide a 401(k) plan with generous company contribution and match, flexible spending accounts, and life and disability insurance. Our paid time off policy is generous, including PTO, sick leave, and paid holidays.

Be a part of our team today!

Document Control Specialist

Hourly Rate: $30.00 to $40.00 per hour

Location: This is an onsite position based at the Company's San Diego facility.

JOB PURPOSE

The Document Control Specialist is responsible for maintaining and administering the Quality Management System (QMS) documentation in accordance with ISO 9001/ISO 13485, applicable regulatory requirements, and company procedures across all Lighteum Medical sites.

The Document Control Specialist serves as a key resource for maintaining document integrity throughout the product lifecycle and supports cross-functional teams including Quality, Manufacturing, Engineering, Supply Chain, and Operations to ensure compliance and operational excellence.

PRINCIPAL ACCOUNTABILITIES

• Administer and maintain controlled documents within the electronic document control system (MasterControl) for all Lighteum Medical sites.
• Manage user access, workflows, templates, and document lifecycle within MasterControl.
• Ensure electronic signatures comply with 21 CFR Part 11 requirements.
• Ensure integrity, traceability, version control, and security of controlled documents and electronic quality records.
• Process document changes including creation, revision, review, approval, issuance, and obsolescence of quality system documentation.
• Maintain document control activities for procedures, work instructions, forms, specifications, drawings, travelers, inspection plans, and other quality records.
• Coordinate Engineering Change Orders (ECOs) and quality system change requests.
• Ensure all documentation complies with ISO 9001 / ISO 13485 requirements and internal quality procedures.
• Verify document accuracy, formatting, revision history, and approval requirements before release.
• Control the distribution of current revisions and prevent the unintended use of obsolete documents.
• Maintain document retention and archival processes in accordance with company policies and regulatory requirements.
• Support training activities by ensuring employees are assigned and trained to revised or newly released documents.
• Monitor document control metrics such as document turnaround times, overdue approvals, and training completion status.
• Support internal, customer, and external audits by providing controlled documentation and quality records.
• Participate in management of nonconformance, CAPA/CAR, risk management, supplier quality, and other quality system records as assigned.
• Collaborate with Manufacturing and Engineering to ensure production documentation accurately reflects approved manufacturing processes and specifications.
• Assist with implementation and continuous improvement of document control processes and quality system workflows.
• Coordinate document-related employee training assignments and monitor completion to ensure training compliance prior to document effective dates.
• Other duties as assigned.

QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE

High School diploma or equivalent

Essential

Associate's or bachelor’s degree in Engineering, Business Administration, Life Sciences, or a related field.

Preferred

Minimum of 2 years of document control or quality systems experience in a regulated manufacturing environment.

Essential

Experience working within an ISO 13485 Quality Management System

Essential

Understanding of ISO 13485 document and record control requirements

Essential

Experience in medical device manufacturing or medical device component manufacturing

Essential

Experience with eQMS software systems such as MasterControl

Essential

Strong written and verbal skills

Essential

Ability to manage multiple document changes simultaneously while meeting deadlines

Essential

Lighteum Medical is an Equal Opportunity Employer and encourages applications from qualified candidates regardless of sex, race, disability, age, sexual orientation, marital status, religion, belief, or any status protected by federal, state, or local law. If you require a reasonable accommodation to apply or participate in the interview process, please contact [e-mail].