What are the responsibilities and job description for the Document Control Specialist position at Carlsmed?
Position Description
As a Document Control Specialist, you will manage and maintain controlled documents, ensuring compliance with FDA regulations, and supporting quality assurance processes. You will oversee the entire documentation lifecycle, from creation and approval to distribution and archiving, playing a critical role in audit readiness and regulatory submissions. Your work will directly impact product release approval by ensuring that all required documentation is accurate, compliant, and readily available, contributing to the safe and efficient delivery of products to market.
We are seeking a detail-oriented and proactive person to join our team. This role requires a blend of organizational skills, technical expertise, and a commitment to our core values: Be Patient-Obsessed, Do What Is Right, and Achieve Together.
See our core values in action for this position – Be Patient Obsessed: Ensure timely and accurate documentation that supports product safety and quality, ultimately prioritizing patient outcomes and well-being; Do What Is Right: Maintain the highest standards of integrity and compliance in all documentation practices, ensuring all records meet regulatory and quality requirements; and Achieve Together: Collaborate with team members and stakeholders to streamline document control processes and contribute to shared success.
Responsibilities
- Manage document change control process – Oversee creation, review, approval, and revision of controlled documents (SOPs, work instructions, design history files, risk management files, and validation protocols) through an electronic document management system (EDMS)
- Monthly audit of released change orders
- Train employees on document control procedures – educate employees on document management protocols, including proper documentation practices, change control processes, and compliance requirements; monitor and facilitate training reminders to ensure compliance
- New employee onboarding – train new employees on the use of the electronic documentation system and the change process requirements
- Documentation archiving – process and archive device history records
- Maintain documentation on SharePoint
Qualifications
- Minimum of 3 years experience in document control in a FDA environment
- Experience with auditing records
- Familiarity with FDA and ISO regulations
- Experience with an Electronic Document Management System (EDMS)
- Experience using Sharepoint
Skills
- Excellent verbal and written communication
- Audit and compliance readiness – ability to prepare documents for internal and external audits
- Knowledge of Quality Management System (QMS) – Experience working within a QMS to support compliance efforts
- Strong attention to detail
- Proficiency in excel
- Highly organized
Equal Opportunity Employer
Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.
Compensation
We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected hourly rate of pay is $28.00 to $32.00. Compensation may vary based on related skills, experience, and relevant key attributes.
Salary : $28 - $32
