Document Control Coordinator (Contractor)

COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!

POSITION SUMMARY

Coordinate the control of documentation such as Standard Operating Procedures (SOP's), Work Instructions, Protocols & Reports, and raw data archive and quality record retention programs.

 POSITION QUALIFICATIONS

Knowledge: Acquired through education, certifications, training, experience.

• Knowledge of GMPs/QSR, ISO, and other regulatory guidelines. 
• Strong attention to detail. Work well under minimum supervision. 
• Familiarity with electronic document management systems (EDMS)
• Flexible with management of records across different departments.

Skills & Abilities: 

• Basic computer skills, including experience with word processing, spreadsheets, flowcharting and relational databases.
• Expert ability to read and interpret documents and reports. 
• Must have excellent proofreading, spelling, grammar skills and technical writing ability.  
• Ability to speak effectively before groups of customers or employees of the organization. 
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. 
• Ability to compute rate, ratio, and percent.  
• Must be able to use the metric system. 
• Ability to apply common sense in carrying out instructions furnished in written, oral, or diagram form. 
• Ability to deal with problems involving several concrete variables in standardized situations. 
• Desire and ability to communicate on a regular basis with all members of management and scientific staff regarding work in progress and any potential problems.  
• Ability to prioritize, foresee problems and make decisions to avoid conflicts in work requests.

Level of Experience: 

2-3 years’ experience in a medical device, drug, or related ISO regulated field.

Level of Education: 

Associates degree is preferred. 

Travel: 

None.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Utilize ERP systems and maintain databases in support of operations, including auditing data, updating product statuses, and managing information obsoleting.
• Work with Marketing Product Management teams to ensure part number and data base accuracy and current content.
• Manage the final disposition process and process contributors of product inventory as products reach their end-of-life process and become discontinued.
• Perform updates to documentation through an FDA and ISO13485 quality management system (QMS)
• Identify and report item, inventory level, and order information to other departments
• Expedite documentation to support product end-of-life activities for purchased, molded, assembled devices through product lifecycle.
• File management of specification Bill of Material (BOM) and associated technical documentation and Instructions For Use (IFU)
• Use MS Excel to create analysis and maintain key performance indicators essential for progress monitoring and process improvement within the department and for the organization.
• Assist with special projects as assigned.
  

OTHER RESPONSIBLITIES

• Focus on achieving our Company mission. 
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
• Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
• Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
• Contribute to building and maintaining a positive team environment.
• Assure all policies and guidelines are implemented and followed.

QUALITY POLICY

At AirLife, Quality is our promise.  It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA STATEMENT

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.