- Field
- Quality engineering and management
- Location
- Bay Shore, NY
- Work model
- Onsite
- Level
- Mid
- Pay
- $90k to $110k
About the role
Your focus will be on quality control, assurance, and continuous improvement, ensuring our products meet regulatory requirements and customer expectations.
What you would own
- Quality Design & Development: Collaborate closely with cross-functional teams to support Quality Design and Development (QD&D) activities during the Product Development Process.
- Ensure that all quality requirements are clearly defined, implemented, and adhered to throughout the design and development stages.
- Product Development Process (PDP): Participate in the planning, execution, and monitoring of quality assurance measures during new product development.
- Conduct risk assessments, design validation, and verification activities to ensure the product meets design intent and regulatory standards.
- Provide ongoing quality support to sustaining manufacturing teams.
- Identify, investigate, and resolve quality issues in manufacturing processes to maintain consistent production standards.
- Lead root cause analysis and implement corrective actions as needed.
- Product Distribution & Post-Market Support: Ensure quality assurance during product distribution and provide support for post-market surveillance activities.
- Monitor product performance and collaborate with field teams to address any quality concerns that arise in the market.
- Compliance & Regulatory: Ensure compliance with all applicable regulatory standards, including ISO, FDA, and other relevant industry regulations.
- Prepare and maintain required documentation to support regulatory submissions and audits.
- Drive continuous improvement initiatives in quality processes, systems, and procedures.
- Utilize data analysis and metrics to identify areas for improvement and implement effective solutions that enhance overall product quality and efficiency.
- Collaboration & Communication: Work closely with engineering, manufacturing, and supply chain teams to foster a culture of quality throughout the organization.
- Communicate quality expectations clearly and collaborate on best practices to achieve common goals.
What they are looking for
- Bachelor's degree in engineering, quality management, or a related field.
- Proven experience as a Quality Engineer, preferably in a manufacturing or product development environment.
- Strong knowledge of quality assurance methodologies, product development processes, and regulatory requirements.
- Proficient in risk management, root cause analysis, and corrective/preventive action processes.
- Excellent communication and problem-solving skills.
- Certification in quality management systems (e.g., Six Sigma, ASQ Certified Quality Engineer) is a plus.
Everything above is the hiring company’s own words, with the company name taken out. The name, the team, and the interview steps come with the first conversation.