The QA Compliance Manager is responsible for the implementation and continuous improvement of the BDI site Regulatory Compliance and the Audit program. In this role, he/she is responsible for the identifying and implementing quality and regulatory compliance initiatives based on current and forthcoming regulatory compliance requirements as well as oversee and executes the local internal audit program at BDI facilities, products, manufacturing processes and providing training and guidance for the site audit team members and site management. He / She assists the Head of Quality and Plant Site Management with the planning of required annual audits and other audits as needed and assigned. He / She conducts training and coaching of local audit team members on the how to conduct audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks as well as review / evaluate adequate completion of all planned actions via supporting documentation. He / She monitors the timely completion of corrective action plans and coordinates / performs the reporting of compliance metrics to site manufacturing facilities management during management reviews. He / She functions a subject matter expert for quality and regulatory compliance issues.
MAJOR DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
· While performing the duties of this job, the employee is frequently required to stand; walk; use hands or arms (to finger, handle or feel objects, tools, or controls). The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.
· The noise level in the work environment is normally quiet to moderate.
· 100% of day spent indoors.
· Domestic and international is required (5-10%).
Job Updated September 2018