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at RR Donnelley
The primary purpose of the position is to support the medical device business and ensure that the Quality System, and all required processes and practices comply with all necessary regulatory, quality system and business requirements as based on ISO 13485 and FDA requirements for medical device manufacturing. Reporting to the site Quality Mgr., the person will need to work closely with the Account Teams, Quality Engineers, Materials Department and any other groups necessary.
Interact and communicate with the different departments and quality engineering to evaluate specifications drawings, rework instructions, deviations and procedures.
Conduct first article inspections
Conduct label approvals
Manage departmental measurement processes
Provide back-up for QMS administrator, quality clerks and training coordinator
Provide support for QEs in the following areas:
*Reviewing, investigating and responding to customer complaints
*Evaluating change requests from customers
*Maintenance of deviation database
*Maintenance of customer complaint database
*Providing research related to floor activities
*Providing project support activities as needed
*Supporting corrective actions activities on floor
*Providing reports as needed to customers
Help train support quality personnel on how to interpret specification drawings, rework instructions and procedures.
Contribute to the development of work instructions and QMS procedures
Provide support for all second and third party audits
Maintain all records in a manner compliant with all regulatory and QMS Requirements.
Participate in and satisfactorily complete all training programs required of the assigned position.
Perform other duties as assigned.
RRD is an EEO/AA including Vets and Disabled Employer
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must have to ability to communicate effectively and professionally as well as work well with others at all levels.
Must be able to work on personal initiative, have the flexibility to mange change, multi-task and be able to prioritize.
Must have excellent computer skills, Microsoft Office, Excel, Word, Power Point.
JD Edwards or an ERP system experience a plus
Working knowledge of lean manufacturing principles.
Experience in a regulatory industry, preferably medical
Knowledge of cGMPs