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 :
- Receive, review, and maintain applicable standards, statutory / regulatory 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;
- and / or 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 Action / Preventative 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, and / or audits on Deringer-Ney suppliers, as necessary.
- Research, communicate, and address new statutory, and / or regulatory requirements throughout the organization when / where 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 Skills / Abilities :
- Strong communication skills. Must be able to present compliance risks, analysis results, and improvement opportunities effectively throughout the organization on a timely basis.
- Organized. 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 documentation.
- Computer 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, and
- presentation 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) and / or significant professional experience may be considered in lieu of certain educational requirements.
- Auditing and training experience is preferred.
- Background in an ISO 13485-certified and / or 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.
30+ days ago