Quality Engineer

6 Degrees Search; Bay Shore (NY); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

6 Degrees Search is seeking a Quality Engineer to oversee quality design and development across the product lifecycle. You will collaborate with cross-functional teams to define and implement quality requirements during the PDP, support sustaining manufacturing, and ensure compliance with ISO and FDA standards.

You will lead risk assessments, design validation, and corrective actions, while supporting post-market surveillance and continuous improvement initiatives to enhance product quality and

Qualifikationen

• Must have hands-on experience in quality assurance methodologies and product development processes.
• Experience with regulatory requirements (ISO, FDA) is preferred.
• Strong problem solving and communication skills required.

Aufgaben

• Collaborate with cross-functional teams to support QD&D activities during PDP.
• Plan, execute, and monitor quality assurance measures in new product development.
• Lead root cause analysis and implement corrective actions in manufacturing.
• Ensure quality during product distribution and post-market surveillance.
• Maintain documentation for regulatory submissions and audits.
• Drive continuous improvement in quality processes and metrics.
• Communicate quality expectations and best practices across engineering, manufacturing, and supply chain.

Kenntnisse

Quality engineering

Risk management

Root cause analysis

Effective communication

Six Sigma

ASQ CQE (certification)

Ausbildung

Bachelor’s degree in engineering or quality management

Jobbeschreibung

As a Quality Engineer, you will play a crucial role in ensuring the highest level of quality standards are met during the Product Development Process (PDP) and throughout the lifecycle of our products. This includes participating in the Quality Design and Development (QD&D) efforts during the initial design phase as well as providing ongoing support for sustaining manufacturing and product distribution. Your focus will be on quality control, assurance, and continuous improvement, ensuring our products meet regulatory requirements and customer expectations.

Key Responsibilities:

• 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.

• Sustaining Manufacturing Support:
  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.

• Continuous Improvement:
  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.

Qualifications:

• 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.