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.