Quality Assurance Engineer

Location: Bay Shore, NY

As a Quality Engineer, you will be responsible for upholding high-quality standards throughout the Product Development Process (PDP) and product lifecycle. Your role involves active participation in Quality Design and Development (QD&D) efforts in the design phase, as well as providing ongoing support for manufacturing and distribution processes. Focus areas include quality control, assurance, and continuous improvement to meet regulatory requirements and customer expectations.

Key Responsibilities:

• Quality Design & Development: Collaborate with cross-functional teams to ensure quality requirements are met during the design phase.
• Product Development Process (PDP): Plan, execute, and monitor quality assurance measures for new product development.
• Sustaining Manufacturing Support: Identify and resolve quality issues in manufacturing processes.
• Product Distribution & Post-Market Support: Ensure quality during product distribution and support post-market surveillance.
• Compliance & Regulatory: Ensure compliance with regulatory standards.
• Continuous Improvement: Drive quality process improvements and implement solutions.
• Collaboration & Communication: Work with cross-functional teams to promote a quality culture.

Qualifications:

• Bachelor’s degree in engineering, quality management, or related field.
• Proven experience as a Quality Engineer in manufacturing or product development.
• Knowledge of quality assurance methodologies, product development processes, and regulatory requirements.
• Proficiency in risk management, root cause analysis, and corrective/preventive action processes.
• Excellent communication and problem-solving skills.
• Certification in quality management systems is a plus.