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Document Control Specialist- Contract, Grand Rapids, MI
2 months ago
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
This position has multiple roles, primarily responsible for creation, review, and editing of technical documentation for manufacturing, testing, labeling and change control activities. Ability to maintain a good working relationship with co-workers and the general public. Capable of good time management to assure judicious organization and completion, and filing of all records (i.e., hard documentation and software based)
POSITION QUALIFICATIONS
The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.
Knowledge:
Acquired through education, certifications, training, experience.
Level of Experience:
Minimum of two years in a documentation supported activity
Level of Education:
High School Education, AS Degree preferred
Travel: None
ESSENTIAL DUTIES AND RESPONSIBILITIES
The core tasks, duties, and responsibilities that must be performed on the job.
- Maintain databases in support of operations, including assigning new component, subassembly, and assembly part numbers.
- Work with Marketing to assure part number data base is accurate and current.
- Assist in review of FDA export documentation
- Design, formatting, and maintenance of critical document files such as device history records, bill of materials, drawings, document change notices, training records, molding and extrusion process validations, test methods, calibration procedures, SOP’s, OI’s. etc.
- Support Production in the generation of labeling.
- Expedite documentation for purchased, molded, assembled devices through production
- File management of specification Bill of Material (BOM) and associated technical documentation
- Manufacturing General Dimensioning and Tolerance knowledge a plus
- Special projects as assigned
OTHER RESPONSIBILITIES
- 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.
