Document Control Administrator I

Quality Mechanicsburg, PA
Salary: USD 21.00 - 25.00 Hourly


We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.
 
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
 
Who We’re Looking For:
As a key member of the Quality team, the Document Control Administrator I ensures that all controlled documents are accurate, up-to-date, and distributed appropriately. This role plays a critical part in maintaining compliance with regulatory standards in a medical device environment.
 
About the Role:
  • Review technical documents for accuracy, completeness, and adherence to formatting standards.
  • Edit and update controlled documents such as standard operating procedures (SOPs), work instructions, and technical manuals.
  • Distribute controlled documents to internal teams and ensure proper version control.
  • Monitor document workflows and approvals to ensure timely processing.
  • Assist in maintaining compliance with FDA regulations and ISO standards by following established procedures.
  • Respond to request for documentation from internal teams or external auditors.
 
Minimum Qualifications:
  • High school diploma or equivalent with 1-2 years of prior related job experience.
  • Developing knowledge of regulatory requirements and product families and existing knowledge of quality and engineering standards.
  • Good communication, organizational and time management skills.
  • Proficiency with Microsoft Office applications.
  • Familiar with ISO 13485, medical device quality and safety requirements.
  • Demonstrated command of the English language (oral and written).
 
Why Laborie:
Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.
  • Paid time off and paid volunteer time
  • Medical, Dental, Vision and Flexible Spending Account
  • Health Savings Account with Company Funded Contributions
  • 401k Retirement Plan with Company Match
  • Parental Leave and Adoption Services
  • Health and Wellness Programs and Events
  • Awarded 2024 Cigna Healthy Workforce Designation Gold Level

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.