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Product Compliance Engineer

Newark, NJ 07102

Posted: 05/24/24 Employment Type: 6 months contract Industry: Other Job Number: 14251605

Job Description

Job Summary/Basic Function:
As a Product Compliance Engineer, you will play a critical role in ensuring that products meet regulatory requirements, adhere to industry standards, and uphold the company's commitment to quality, safety, and compliance. Your primary objective will be to maintain the highest level of product safety, government compliance and mitigate potential hazards that could lead to customer harm or legal disputes.

There is a strong emphasis on technical aspects of this profession, scientific understanding, and strong project management. Professionals in this role expand their involvement in international/multinational regulatory issues and begin a more active involvement with concepts of regulatory strategy and people management. Your role involves collaborating with cross-functional teams, conducting thorough inspections and tests, and maintaining up-to-date knowledge of applicable laws and industry standards. By meticulously evaluating product designs, materials, and manufacturing processes, you will contribute to the development of safe, reliable, and legally compliant products. Your expertise will be instrumental in protecting both the company's reputation and the well-being of its customers.

A Product Compliance Engineer demonstrates knowledge and skills in areas such as, not limited to, regulatory frameworks; documentation; risk-benefit analysis; communication and collaboration internally and externally; working with vendors and subcontractors; submission, registration, obtaining approval, documentation, compliance, and post-marketing surveillance. Individuals in this role focus on hands-on training to strengthen and develop new skills and knowledge.

Basic Qualifications • Reports to PNA PEXNA Safety, Compliance and Quality Assurance Group Manager Education & Experience: • Bachelor's degree in engineering, product safety, industrial design, or a related field plus generally 3-5 years’ experience. A master's degree is preferred. • Proven experience as a product safety engineer or in a similar role. • In-depth knowledge of product safety regulations, standards, and best practices, such as ISO 9001, ISO 14001, and IEC 62368. • Strong understanding of risk assessment methodologies and hazard analysis techniques. • Experience in conducting product testing, compliance assessments, and root cause analysis. • Excellent analytical and problem-solving skills with a keen attention to detail. • Effective communication and presentation skills to deliver training and communicate complex safety information to various stakeholders. • Strong project management abilities with the ability to manage multiple tasks and priorities simultaneously. • Familiarity with legal requirements and procedures related to product liability and recalls. • Certification in product safety or related areas (e.g., Certified Product Safety Engineer) is a plus. Management • Responds quickly to issues escalated. • Ensures superior Business Division and factory satisfaction with services. • Monitors processes and solutions, ensuring they meet both Business Division and factory and company needs • Proactively identifies and removes barriers that would prevent from meeting our customer needs • Generate timely, complete, and accurate updates. Problem Solving: • Analyzes complex data and identifies trends, relationships, and patterns. • Understands causes and effects/ • Approaches problems with own and other’ perspective in mind; recognizes other ways to tackle problems. • Supports and encourages others to produce a range of workable solutions Communications: • Speaks clearly and articulately. • Speaks with authority and conviction when working with peers, Business Division and factory staff. • Communicates information in a clear and easy to understand manner and ability to work with personnel at all management levels both inside and outside the company. • Quickly gets to the point in communications; communications are concise. • Provides information to the team about important company policies and initiatives. • Good presentation skills required to ensure clarity and audience engagement. Other Requirements: • Business travel: As directed.

 ACCOUNTABILITY: Product Safety, Government Compliance and Market Quality
• Regulatory Compliance Assurance: Ensuring that all products meet the regulatory requirements and standards set by relevant authorities in the regions where they are sold or distributed. This includes monitoring changes in regulations, interpreting their implications for product design and manufacturing, and implementing necessary adjustments to maintain compliance.
• Risk Assessment and Mitigation: Identifying potential compliance risks associated with product design, materials, manufacturing processes, and usage scenarios. Developing and implementing strategies to mitigate these risks effectively, such as redesigning products, selecting alternative materials, or implementing additional safety measures.
• Product Testing and Evaluation: Planning, coordinating, and executing comprehensive testing programs to assess product safety and performance impact. This involves selecting appropriate testing methodologies, conducting tests in accordance with relevant standards and protocols, and analyzing test results to ensure compliance.
• Documentation and Record-Keeping: Maintaining accurate and up-to-date records of compliance activities, including test reports, certification documents, regulatory submissions, and correspondence with regulatory agencies. Ensuring that all required documentation is complete, organized, and readily accessible for audits, inspections, and reporting purposes.
• Cross-Functional Collaboration: Collaborating closely with internal teams, including product development, engineering, manufacturing, quality assurance, and legal departments, to integrate compliance considerations into the product lifecycle. Providing guidance and support to ensure that compliance requirements are understood and addressed throughout the development and manufacturing processes.
• Continuous Improvement: Proactively identifying opportunities to enhance compliance processes, procedures, and standards to ensure ongoing adherence to regulatory requirements and industry best practices. Implementing improvements and monitoring their effectiveness to drive continuous improvement in product compliance performance.

• Training and Education: Providing training and guidance to internal teams on compliance-related matters, including regulatory requirements, testing methodologies, and best practices for ensuring product compliance. Promoting a culture of compliance awareness and accountability throughout the organization through effective communication and education initiatives.
• Audit and Inspection Support: Supporting internal and external audits and inspections related to product compliance, including preparing documentation, facilitating interviews and site visits, and addressing any findings or non-compliance issues identified during the audit process. Implementing corrective and preventive actions as needed to address compliance deficiencies and prevent recurrence.

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