Sr. Quality Engineer- NPI
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Job Description
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.
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Submit 10x as many applications with less effort than one manual application.