Description
Job Description:* Technical writing including researching of reference documentation and applicable standards
* Serve as a company-wide resource for creation, revision, and retention of controlled documents and records
* As directed by supervisor, participate in development of new documentation for products in various stages of the design process
* Evaluate and process engineering change orders (ECO's) and electronic protocols and reports (ePR's) for completeness and adherence to procedure
* Ensure appropriate distribution of Quality System documentation to controlled books and suppliers
* Word processing, data entry, and database management
* Initiate and independently pursue projects needed for compliance, corrective action, etc.
* Comply with applicable FDA and international regulatory laws/standards
* Coordinate annual archiving of quality records and serve as resource for retrieval of archived records
* Participate in providing document/data records as required to satisfy internal and external audits and in support of complaint investigation
Requirements:
* 5+ years of related experience in medical device or health care industry
* Computer/networking experience with MS Office software applications. Experience with PLM and ERP software a plus.
* Strong technical writing and editing skills
* Detail oriented and self-directed with good time management skills
* Knowledge of electronic change orders (ECO) in medical device industry
* Knowledge of the Product Development Process (PDP) in a medical device industry
* Good interpersonal skills and the ability to perform effectively in a fast paced, multi-faceted environment
* Knowledge of Quality System practices including ISO/EN guidelines, QSR, and 21 CFR Part 11
* Knowledge of PLM and ERP software a plus
* Ability to function as part of a team and achieve results through open collaboration with others
* Results oriented with the ability to be accountable to the achievement of both individual and team goals
* 'Customer First' mentality with excellent customer service skills in support of internal groups
To find out more about Real please visit www.realstaffing.com