Title: Compliance Specialist
Job Summary:
Oversee compliance requests and requirements to ensure that statutory, regulatory, and customer specific requirements are met (i.e., Export Controls/ITAR, FARs, DFARs, REACH, RoHS, Conflict Minerals/CMRT, FDA, etc.). Support and/or drive overall implementation, maintenance, and continual improvement of Quality Management Systems (QMS) to achieve compliance.
Supervisory Responsibilities: No
Duties/Responsibilities:
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Receive, review, and maintain applicable standards, statutory/regulatory requirements, and customer specific requirements in an electronic database, along with appropriate notes and exceptions.
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Own process flows related to compliance programs. For instance:
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Export Control compliance reviews;
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ITAR protocols;
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conflict mineral smelter qualification;
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FARs and DFARs;
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EAR, export licensing guidelines, and harmonized tariff codes;
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restricted substance compliance analysis;
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International Material Data System (IMDS) and full material disclosure reporting;
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medical device history record compliance;
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and/or other compliance procedures.
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Provide excellent customer service by compiling and communicating compliance surveys and questionnaires to Deringer-Ney’s customers.
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Support contract manufacturing opportunities through specification review, using the Engineering Change process as appropriate.
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Capture findings and provide feedback on any gaps between current systems and practices and those required by standards and specifications, utilizing the Corrective Action/Preventative Action process when necessary.
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Report to Senior Management regularly on the performance of the Quality Management System with respect to compliance and any need for improvements.
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Develop metrics and methods of monitoring to ensure compliance health.
ADDITIONAL RESPONSIBILITIES:
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Work in conjunction with the Quality Assurance Manager to ensure Quality Management System is configured maintained in accordance with applicable standards and regulations.
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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).
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Develop and maintain knowledge of export control regulations through training such as BIS.
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Support audits by internal auditors, registrars, customers, and/or audits on Deringer-Ney suppliers, as necessary.
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Research, communicate, and address new statutory, and/or regulatory requirements throughout the organization when/where required.
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Ensure DNI training materials pertaining to compliance are up-to-date and correct; assist in training when required.
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Perform internal product and process audits in areas both related and unrelated to compliance.
Required Skills/Abilities:
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Strong communication skills. Must be able to present compliance risks, analysis results, and improvement opportunities effectively throughout the organization on a timely basis.
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Organized. Will be expected to prioritize and execute several different tasks with various internal and external stakeholders.
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Detail-oriented. Will have a natural ability to pay attention to fine detail during the review of specifications and documentation.
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Computer skills required to navigate various software packages commonly used in compliance. This includes:
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electronic quality databases (i.e., Unipoint),
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enterprise resource planning systems (i.e., Made2Manage),
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PDF processing tools (i.e., Adobe Acrobat),
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word processing, and
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presentation management software.
Experience & Education Requirements:
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Background in ISO 9001 system management and specification review is required for the position.
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Bachelor’s Degree preferred, although certain vocational training (i.e., paralegal) and/or significant professional experience may be considered in lieu of certain educational requirements.
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Auditing and training experience is preferred.
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Background in an ISO 13485-certified and/or IATF 16949-certified quality system management is preferred.
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FDA regulations (i.e., CFR), medical industry compliance requirements, and other international standards that regulate the medical device industry is preferred.
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Knowledge of automotive industry customer-specific requirements, and relevant associated standards (i.e., CQI, etc.) is preferred.
Physical Requirements:
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Prolonged periods of sitting at a desk and working on a computer.
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Must be able to lift 15 pounds at times.
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Must be able to access and navigate each department at the organization’s facilities.