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 ( actalentaccommodation@actalentservices.com) for other accommodation options.