POSITION SUMMARY:

We are seeking a Senior Quality Engineer – New Product Introduction (NPI) to join our team and ensure the quality and reliability of new products from concept through launch. This role is critical in driving quality excellence throughout the product development lifecycle, ensuring that all deliverables meet internal requirements, regulatory standards, and customer expectations.
The ideal candidate brings strong experience in quality systems, risk management, and process validation, and thrives in a collaborative, fast-paced environment.

QUALIFICATIONS:

• Bachelor’s degree in Engineering, Quality Management, or a related technical field.
• Minimum of 5 years of experience in quality engineering, with a focus on new product development and introduction.
• Certified Quality Engineer (CQE) or equivalent certification is highly preferred.
• Experience working in regulated environments (e.g., ISO 9001, ISO 13485, FDA, etc.)

TECHNICAL SKILLS & COMPETENCIES:

• Proficiency in risk management tools such as DFMEA, PFMEA, and Control Plan development.
• Strong knowledge of GD&T, APQP, PPAP, and statistical quality control methods.
• Skilled in root cause analysis and implementation of corrective actions.
• Proven leadership in cross-functional project teams and a track record of successful NPI launches.
• Excellent communication and interpersonal skills to lead discussions and influence quality decisions.
• Familiarity with stage-gate product development and design control systems.

• Lead quality planning for New Product Introductions (NPI), ensuring alignment with design intent, manufacturing feasibility, and customer expectations.
• Conduct risk assessments (DFMEA, PFMEA) and implement mitigation strategies throughout the product lifecycle.
• Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Oversee and approve key quality documentation and reviews, including Design Inputs, Verification & Validation, Manufacturing Readiness, and Risk Management.
• Support stage-gate product development activities with a focus on quality deliverables and compliance.
• Collaborate cross-functionally with engineering, operations, supply chain, and regulatory to manage and mitigate quality-related risks.
• Develop and maintain Control Plans and contribute to the development of APQP and PPAP deliverables.
• Mentor junior engineers and promote best practices in quality engineering across teams.