Quality Engineer - NPI

Quality Engineer - New Product Introduction (NPI)
Help Shape the Future of Healthcare Innovation

Join a global leader in medical technology that is dedicated to improving patient outcomes through innovative products and solutions. With a reputation for excellence, cutting-edge technology, and a people-first culture, our organization partners with healthcare professionals around the world to advance patient care. We are driven by quality, innovation, and a commitment to making healthcare better.

As a Quality Engineer - NPI, you will play a critical role in bringing new products from concept to commercialization. This position is ideal for a quality professional who thrives in a fast-paced environment and is passionate about validation, risk management, supplier quality, and continuous improvement.

What You'll Do

As a key member of our New Product Introduction team, you will provide technical leadership and quality expertise to ensure successful product launches and robust manufacturing processes.

Key Responsibilities:

+ Champion Design for Manufacturability (DFM) and Design for Assembly (DFA) principles throughout new product development.

+ Partner cross-functionally with Design Engineering, Advanced Operations, Manufacturing, Supply Chain, and Quality teams to deliver seamless design transfers.

+ Lead and support process development activities to ensure manufacturing processes are capable, scalable, and deliver consistent, high-quality outcomes.

+ Drive the development and execution of process validation strategies, including IQ/OQ/PQ activities and validation documentation.

+ Lead risk management activities including PFMEA development, risk assessments, risk mitigation plans, and implementation of effective process controls.

+ Ensure compliance with ISO 14971 and support maintenance of product Risk Management Files.

+ Develop and optimize inspection strategies utilizing CQA, CTQ, MSA, statistical methods, and sampling plans.

+ Conduct data analysis, identify quality trends, and implement corrective and preventive actions (CAPA).

+ Support and approve First Article Inspection (FAI) activities and inspection plans.

+ Collaborate closely with suppliers to resolve quality issues and implement sustainable corrective actions.

+ Lead supplier qualification efforts, including supplier validation activities and Production Part Approval Process (PPAP) approvals.

+ Represent Quality Assurance during design reviews, design transfer milestones, and product launch readiness reviews.

+ Drive continuous improvement initiatives focused on reducing risk, improving process capability, and eliminating quality defects.

What We're Looking For

Required Qualifications:

+ Bachelor's degree in Engineering or a related technical discipline.

+ 3-5+ years of experience in Quality Engineering, preferably within the medical device or regulated manufacturing industry.

+ Strong experience with validation methodologies including process validation and manufacturing qualification activities.

+ Demonstrated expertise in risk management, including PFMEA, risk assessments, risk mitigation, and control strategy development.

+ Hands-on experience leading or supporting PPAP activities and supplier qualification programs.

+ Working knowledge of ISO 14971, quality systems, and regulatory compliance requirements.

+ Experience supporting new product introduction, design transfer, or manufacturing process implementation.

+ Ability to work independently while influencing cross-functional teams and stakeholders.

Preferred Qualifications

+ Expertise with CQA, CTQ, MSA, SPC, and statistical analysis tools.

+ Experience developing predictive and risk-based quality systems.

+ Knowledge of lean manufacturing, process improvement, and value stream mapping.

+ Experience supporting CAPA, nonconformance investigations, and root cause analysis.

+ Strong communication, leadership, and project management skills.

Why Join Us?

+ Be part of a mission-driven organization focused on improving lives through medical innovation.

+ Work alongside talented professionals in a collaborative and highly innovative environment.

+ Influence the development and launch of products that make a real difference for patients worldwide.

+ Competitive compensation and comprehensive benefits package.

+ 3 weeks of PTO plus 10 paid holidays.

+ Opportunity for professional growth, career advancement, and leadership development.

Work Environment

+ Full-time, onsite position.

+ Collaboration-driven environment with daily interaction across engineering, operations, and quality teams.

+ Five days per week onsite.

If you're passionate about quality excellence and have strong expertise in validation, risk management, and PPAP, we'd love to hear from you!

Job Type & Location

This is a Contract position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $55.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and…