Description:

• 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
• 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
• Export Control compliance reviews; ITAR protocols;
• Provide excellent customer service by compiling and communicating compliance surveys and questionnaires to 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
• Develop and maintain knowledge of export control regulations through training such as BIS
• Support audits by internal auditors, registrars, customers, and/or audits on suppliers, as necessary
• Research, communicate, and address new statutory, and/or regulatory requirements throughout the organization when/where required
• Perform internal product and process audits in areas both related and unrelated to compliance

Additional Skills & Qualifications:

• FARs and DFARs;
• Restricted substance compliance analysis
• International Material Data System (IMDS) and full material disclosure reporting
• Medical device history record compliance and/or other compliance procedures
• Strong communication skills
• Must be able to present compliance risks, analysis results, and improvement opportunities effectively throughout the organization on a timely basis
• 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 enterprise resource planning systems (i.e., Made2Manage), PDF processing tools (i.e., Adobe Acrobat),
• Background in ISO 9001 system management and specification review is required for the position

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.