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Job Description
This role will be 100% onsite.
- Job Description Summary
o Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio.
o Looking to hire somebody with Manufacturing Engineering and Design expertise to review the Specification of Product and Part requirement with R&D and design assurance against of part/product risk management file.
o Hands on driving and performing IQ, OQ, PQ and TMV at the suppliers.
o Strong Communicator to manage stakeholders and provide bi-weekly update to Senior Leadership management.
o Minimum of 20% travel in North America
- Job Description
- Review and assess the OQ/PQ/IQ of suppliers and support the supplier over TMV challenges.
- Responsible for End-to-End assessment on Supplier Performance (NCRs, SQNs, SCARs, SICRs,)
- Successfully integrates across multiple product lines and businesses
- Thorough knowledge of the business areas supported including their strategies, goals, competitive environment, functional processes, and organizational dynamics
- Fosters excellent cross-functional communications and integrates the work of managers to achieve business objectives.
- Navigate within ambiguity and drive resolution within Quality Management System.
- Strong Communicator, experienced in Statistical analysis, and power point presentation.
- Minimum of 10 years of related engineering experience (medical device or regulated industry preferred).
- Broad cross functional experience.
- Advanced Quality Engineering and Continuous Improvement skills.
- Direct working relationships with suppliers
- Leadership exposure in a technical capacity
- Project Management practice
- Direct shop-floor production engineering sustaining experience
Job Responsibilities
- Manages the development and implementation of a comprehensive trade compliance framework, encompassing Free Trade Agreements, customs compliance procedures, and export control regulations, ensuring proper application, adherence, and archiving of these frameworks.
- Leads global customs classification projects, ensuring accurate and consistent classification of goods across all regions to facilitate smooth international trade operations.
- Oversees daily customs and trade compliance operations, ensuring all activities comply with relevant regulations and internal policies, managing risk and resolving compliance issues promptly.
- Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
- Plans and executes continuous improvement initiatives related to business and compliance processes, leveraging Lean Leadership principles to enhance efficiency and effectiveness.
- Develops and executes trade compliance policies and roadmaps based on the latest regulatory developments, ensuring the company remains compliant and competitive in the global market.
- Prepares and leads trade compliance assessments and audits, including follow-up actions, ensuring all findings are addressed and compliance standards are maintained.
- Mentors and coaches, the global trade compliance community within the company, developing capabilities and fostering a culture of continuous learning and improvement.
- Establishes and assures adherence to budgets, schedules, work plans, and performance requirements, driving operational excellence through effective management and continuous improvement of trade compliance processes.
- Creates a working environment that continuously improves the health and safety of workers, including the identification and management of occupational risks, provision of training, and review of performance.
- Acts as a subject matter expert on trade compliance, providing guidance and support to various business units and ensuring compliance with complex international trade regulations.
- Focuses on a 2-5-year horizon, planning and preparing for future trade compliance challenges and opportunities to align with the company's long-term strategic goals.
Minimum Required Qualifications
Education
Bachelor's / master's degree in business administration, Supply Chain Management, Customs Administration or equivalent.
Work Experience
Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Supply Chain Management, Export Compliance, Trade Compliance or equivalent.
Benefits:
Paid sick leave, Medical/Dental (optional), 401 (k) Retirement Plan (optional), Employer Paid Life Insurance, Employer Paid Short Term Disability, Optional Life Insurance.
ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.