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Document Control Specialist Jobs

Company

Avalign Technologies

Address Fort Wayne, IN, United States
Employment type CONTRACTOR
Salary
Category Medical Equipment Manufacturing
Expires 2023-07-01
Posted at 1 year ago
Job Description
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.
The Document Control Specialist is responsible for collecting, maintaining, and distributing all documents necessary to define product configuration and control mfg. processes that insure conformance to customer requirements. The Document Control Specialist develops and maintains a comprehensive filing system and computer database for all documents to be retained in the document control center. Defines standards and workflows for document management as well as supervises the collection, authoring and publication of documents. Will design workflows and controls that are consistent with ISO 13485.
Duties/Responsibilities: include the following. Other duties may be assigned:
  • Supervise the document lifecycle for business policies and procedures.
  • Maintain document listing which may include but not limited to: Inspection instructions, test procedures, work instructions, operations sheets, internal quality manual, customer quality manuals, material specifications, forms, service contracts.
  • Ability to be flexible with start and stop times to accommodate/prioritize workload and meeting deadlines as well as accommodate workload requirements via OT.
  • Meet with business process owners to define the appropriate document standards and workflows.
  • Prepare document templates, document business rules, roles and responsibilities.
  • Collect and maintain files of the latest revision level documentation necessary to define product configuration and control mfg. processes.
  • Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution.
  • Maintain a computer database of all filed documentation that ensures fast retrieval of documents.
Education and/or Experience:
  • Two to three years of experience in documentation preparation and filing preferred but not required
  • High School Diploma or GED preferred but not required
Physical Demands/Work Environment:
While performing the duties of this job, the employee is required to stand, walk or sit, occasionally for long periods of time; use hands to hold, handle or feel objects; reach with hands and arms; balance; stoop, kneel or crouch; talk or listen. The employee may occasionally lift and/or move up to 50 pounds (seek assistance for greater amounts). Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. The noise level in the work environment is usually moderate.
What You’ll Enjoy:
  • Additional free resources such as travel assistance, EAP, etc.
  • Temperature controlled environment
  • Employer funded STD and LTD insurance
  • Comprehensive medical, dental, and vision insurance
  • Generous employee referral bonus program
  • Competitive compensation and benefits package
  • Employer funded Basic Life and AD&D insurance
  • Working for a thriving, performance-based company that values promoting from within and career advancement
  • Tuition reimbursement
  • Great 401(k) with company match
  • Paid vacation and 10 observed paid holidays per year
  • Community involvement investing and giving back to the community
Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Apply Now