Job Description:

Title: Compliance SpecialistJob Summary:Oversee compliance requests and requirements to ensure that statutory, regulatory, and customer specific requirements are met (i.e., Export ControlsITAR, FARs, DFARs, REACH, RoHS, Conflict MineralsCMRT, FDA, etc.). Support andor drive overall implementation, maintenance, and continual improvement of Quality Management Systems (QMS) to achieve compliance.Supervisory Responsibilities: NoDutiesResponsibilities:Receive, review, and maintain applicable standards, statutoryregulatory requirements, and customer specific requirements in an electronic database, along with appropriate notes and exceptions.Own process flows related to compliance programs. For instance:Export Control compliance reviews; ITAR protocols; conflict mineral smelter qualification; FARs and DFARs;EAR, export licensing guidelines, and harmonized tariff codes;restricted substance compliance analysis;International Material Data System (IMDS) and full material disclosure reporting; medical device history record compliance; andor other compliance procedures.Provide excellent customer service by compiling and communicating compliance surveys and questionnaires to Deringer-Ney's customers.Support contract manufacturing opportunities through specification review, using the Engineering Change process as appropriate. Capture findings and provide feedback on any gaps between current systems and practices and those required by standards and specifications, utilizing the Corrective ActionPreventative Action process when necessary.Report to Senior Management regularly on the performance of the Quality Management System with respect to compliance and any need for improvements.Develop metrics and methods of monitoring to ensure compliance health. ADDITIONAL RESPONSIBILITIES:Work in conjunction with the Quality Assurance Manager to ensure Quality Management System is configured maintained in accordance with applicable standards and regulations.Develop and maintain knowledge and expertise of applicable regulations and ISO Standards. The latter includes ISO 9001, ISO 13485 (medical), ISO 14000 (environmental), and IATF 16949 (automotive).Develop and maintain knowledge of export control regulations through training such as BIS.Support audits by internal auditors, registrars, customers, andor audits on Deringer-Ney suppliers, as necessary.Research, communicate, and address new statutory, andor regulatory requirements throughout the organization whenwhere required.Ensure DNI training materials pertaining to compliance are up-to-date and correct; assist in training when required.Perform internal product and process audits in areas both related and unrelated to compliance. Required SkillsAbilities:Strong communication skills. Must be able to present compliance risks, analysis results, and improvement opportunities effectively throughout the organization on a timely anized. Will be expected to prioritize and execute several different tasks with various internal and external stakeholders.Detail-oriented. Will have a natural ability to pay attention to fine detail during the review of specifications and puter skills required to navigate various software packages commonly used in compliance. This includes:electronic quality databases (i.e., UniPoint),enterprise resource planning systems (i.e., Made2Manage),PDF processing tools (i.e., Adobe Acrobat),word processing, andpresentation management software. Experience & Education Requirements:Background in ISO 9001 system management and specification review is required for the position.Bachelor's Degree preferred, although certain vocational training (i.e., paralegal) andor significant professional experience may be considered in lieu of certain educational requirements.Auditing and training experience is preferred.Background in an ISO 13485-certified andor IATF 16949-certified quality system management is preferred. FDA regulations (i.e., CFR), medical industry compliance requirements, and other international standards that regulate the medical device industry is preferred.Knowledge of automotive industry customer-specific requirements, and relevant associated standards (i.e., CQI, etc.) is preferred.Physical Requirements:Prolonged periods of sitting at a desk and working on a computer.Must be able to lift 15 pounds at times.Must be able to access and navigate each department at the organization's facilities.