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.

• 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.

• 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.