Sr. Quality Engineer- NPI

Position Summary:

The Senior Quality Engineer – New Product Introduction (NPI) is responsible for ensuring the quality and reliability of products during development and launch. This role requires strong expertise in quality engineering, process validation, and cross-functional collaboration to support successful product introductions that meet regulatory standards and customer expectations.

Key Responsibilities:

• Lead quality planning activities for new product introductions, ensuring alignment with design, manufacturing, and customer requirements.

• Conduct risk assessments throughout the product development lifecycle and implement mitigation strategies to proactively address potential quality concerns.

• Drive continuous improvement initiatives to enhance product quality and optimize manufacturing processes.

• Oversee and approve critical quality reviews, including Design Inputs, Design Verification and Validation, Technical and Design Reviews, Manufacturing Readiness, and Risk Management.

• Facilitate and actively participate in DFMEA, PFMEA, and Control Plan development to identify and reduce product and process risks.

• Collaborate with cross-functional teams—including engineering, manufacturing, and supply chain—to identify and mitigate quality-related risks during product development.

• Mentor and train junior quality engineers and team members in quality principles, tools, and best practices.

Qualifications:

• Bachelor’s degree in Engineering, Quality Management, or a related discipline.

• Minimum of 5 years of experience in quality engineering, specifically supporting new product introductions.

• Certification as a Certified Quality Engineer (CQE) or equivalent is highly preferred.

Technical Skills & Competencies:

• Deep knowledge of quality systems and standards such as ISO 9001 and ISO 13485.

• Proficient in risk management methodologies including DFMEA and PFMEA.

• Experience with GD&T, APQP, PPAP, and statistical analysis techniques.

• Strong problem-solving and analytical capabilities.

• Proven leadership and project management skills.

• Excellent communication and interpersonal skills to effectively collaborate with internal teams and external stakeholders.

• Familiarity with stage-gate product development processes.