will be based in. The candidate shall be responsible for organizational adherence to regulatory/agency compliance requirements. This includes ensuring that product safety and/or regulatory compliance processes are implemented in the appropriate organizational functions and providing or obtaining the necessary resources to ensure compliance.
Regulatory Compliance:
- Ensuring that products manufactured by Flex America, LLC. are compliant to customer specified safety standards and applicable regulatory agency standards. (i.e., UL, CSA, TUV, etc.)
- Coordinating all Flex America, LLC. activities associated with maintenance of independent agency approvals on customer products including acting as a liaison between certifying agencies and the customer as required.
- Ensuring that the certified product is manufactured to the specifications and requirements set forth by the customer's specified certifying or listing agencies.
- Coordinating periodic product audits by the certifying or listing agencies, including customer review of nonconformities or defects that are identified during these audits.
- Maintaining all applicable agencyaudit/certification procedures,reports and records including critical component listings.
- Review and approval of all Flex America, LLC. engineering changes, product deviations and component substitutions on products that contain agency sensitive critical parts and/or agency markings.
- Reviewing and maintaining procedures and reports that document or directly affect product safety or regulatory compliance.
- Working with test engineering to ensure test equipment that is used to perform product safety testing on manufactured products is calibrated and programed to the correct parameters.
- Collaborating or supporting the Flex America, LLC. Test procedures for all Hi-Pot test equipment.
Electrostatic Discharge (ESD) Program manger:
- Either have or be willing to obtain the certified ESD program manager certificate to serve as the Subject matter expert (SME) for the site, and local satellite locations.
- Lead the ESD team in activities across the Austin site and satellite locations.
- Own the ESD program, process and governing procedures for the Austin site and satellite locations.
- Own, develop and maintain the site procedures which govern the ESD compliance.
- Provide training for new hire orientation for ESD.
- Work with the Business Solutions team on ESD management for medical devices.
Here is some of what you’ll need (required)…
- Product Safety (Regulatory Agency) background preferred.
- A drive to be detail oriented and an ability to multi-task.
- Experience keeping track of product data sheets and reviewing BOMs (Bill of Materials).
- Ability to write reports, business correspondence and procedure manuals.
- Ability to effectively communicate with managers, employees and customers of the organization.
Here are a few of our preferred experiences…
- Technical degree and relevant experience a plus
- Ability to cross-train team members
- Audit experience; hosting external customers, scheduling internal SME’s (Subject Matter Experts) for audits, Creating Audit agendas and schedules.
- Experience managing ESD Program preferred.
- Knowledge of Hi-pot testing preferred.
What you'll receive for the great work you provide:
- Full range of medical, dental, and vision plans
- Life Insurance
- Short-term and Long-term Disability
- Matching 401(k) Contributions
- Vacation and Paid Sick Time
- Tuition Reimbursement