Sr. Quality Engineer- NPI

The Senior Quality Engineer NPI (New Product Introduction) will play a critical role in ensuring the quality and reliability of new products during the development and launch phases. This position requires deep expertise in quality engineering, process validation, and cross-functional collaboration to drive successful product introductions while meeting regulatory and customer requirements.

• Lead quality planning for new product introductions, ensuring alignment with design, manufacturing, and customer specifications.  
• Risk Management: Conduct risk assessments and implement mitigation strategies to address potential quality issues during the product development lifecycle.
• Process Improvement: Identify and implement process improvements to enhance product quality and manufacturing efficiency.
• Provide direction and approval for critical reviews for Design Inputs, Design verification and Validation, Technical and Design Reviews, manufacturing readiness and Risk Management
• Champion and participate in the running and creation of DFMEA/PFMEA/Control Plan activities to eliminate or reduce product risk
• Collaborate with cross-functional teams (engineering, manufacturing, supply chain) to identify and mitigate quality risks during product development.
• Training and Mentorship: Provide training and mentorship to junior quality engineers and other team members on quality engineering principles and practices.

• Bachelor’s degree in Engineering, Quality Management, or a related field. 
• 5+ years of experience in quality engineering, with a focus on new product introduction.
• Certifications: Certified Quality Engineer (CQE) or similar certification is highly desirable.
• Skills:
  • Strong knowledge of quality systems and standards (e.g., ISO 9001, ISO 13485).
  • Proficiency in risk management tools and methodologies (e.g., DFMEA, PFMEA)
  • Experience with GD&T, APQP, PPAP, Statistical Analysis
  • Excellent problem-solving and analytical skills.
  • Strong leadership and project management abilities.
  • Excellent communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders.  
  • Experience with a stage-gate product development process
  • Ability to work independently and manage multiple projects in a fast-paced environment.