Principal Quality Engineer

Craftech•Ontario, CA

3d•$100,000 - $145,000•Onsite

About The Position

The Principal Quality Engineer leads critical quality engineering activities for Drug Delivery, IVD, and Medtech platform projects. The role drives development, implementation, and oversight of quality systems and process controls across complex programs involving multiple injection-molded and procured components and external design and manufacturing partners. As a subject matter expert in regulatory compliance, validation strategy, and supplier quality, the engineer ensures robust risk management and alignment with customer and regulatory expectations. The position provides technical leadership to achieve quality objectives, advance continuous improvement, and support successful product development and commercialization from concept through commercialization. The role provides quality oversight for design transfer, process validation, supplier controls, and product and process qualification. It collaborates with internal functions and external partners, including consultants, design partners, suppliers, and contract development and manufacturing organizations. The Principal Quality Engineer also leads investigations and CAPA, supports complaints and management review, maintains quality documentation, and coaches teams in quality engineering methods and compliance practices. The position is on-site five days a week and involves light to moderate physical effort, including lifting up to 35 pounds and regularly sitting, standing, using stairs, walking, and bending.

Requirements

Bachelor’s degree in Mechanical, Biomedical, or Industrial Engineering.
At least 8 years of quality engineering experience in the medical device or combination product industry, with significant focus on medical device design and assembly process development.
Proven experience managing suppliers of custom, precision-molded components and assemblies.
Demonstrated success leading quality efforts across cross-functional, multi-organizational teams, including external design, development, and manufacturing partners.
Expertise in design controls, validation (including GR&R and IQ/OQ/PQ), risk management (including pFMEA and fault tree), statistical process control, and root cause analysis.
Strong understanding of FDA requirements, ISO 13485, ISO 14971, 21 CFR Part 820, Good Manufacturing Practices, and Good Documentation Practices.
Knowledge of injection molding processes, tooling qualification, and metrology.
Proficiency in Minitab and application of statistical techniques for validation and quality control.
Organizational and communication skills to collaborate across internal functions and external partners.
Ability to lead technically and influence without direct authority; self-motivated, resourceful, and strategically minded.
Analytical thinking, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
Knowledge of blueprint reading, design review, and approval.
Ability to interpret SPC charts and understanding of statistical techniques.
Ability to maintain organized records and files, with technical expertise in Quality Assurance standards and document control.
Accuracy in measurement and documentation; excellent oral and written communication and ability to interact effectively with internal and external customers.
Initiative and ability to work with minimal supervision; integrity and ethical business practices; thoroughness and focus on quality output; positive, encouraging teamwork; and ability to enforce company policy and values.
Able to work on-site five days a week.
Able to lift up to 35 pounds and perform light to moderate physical effort, including regularly sitting or standing, using stairs, walking, and bending.

Nice To Haves

Advanced degree preferred.
Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma Black Belt or Green Belt preferred.
Lead Auditor experience preferred.

Responsibilities

Serve as technical quality lead for Drug Delivery, IVD, and Medtech platform projects throughout product development and commercialization.
Act as the primary quality engineering authority for complex, multi-component assembly projects involving multiple injection-molded components; support design transfer, validation, and scalability.
Provide quality oversight, supplier controls, and technical leadership for external consultants, design partners, and contract development and manufacturing organizations (CDMOs).
Develop and execute IQ/OQ/PQ process validation strategies for molded and assembled components.
Collaborate cross-functionally to develop and maintain pFMEAs, Control Plans, acceptance criteria, and inspection documentation.
Lead risk-based supplier quality activities, including procured-component qualification, supplier audits, incoming inspection strategies, and non-conformance resolution.
Work with suppliers and contract manufacturers to establish, monitor, and improve quality agreements, incoming quality metrics, and part qualification strategies.
Serve as quality liaison in design and technical reviews with internal and external partners, providing expertise on quality engineering for drug combination products and devices.
Lead technical root cause investigations and CAPA processes, ensuring timely closure and compliance with FDA 21 CFR Part 820 and ISO 13485.
Drive continuous improvement using Lean and Six Sigma tools, including GR&R, DOE, and SPC, to improve yield, reduce variation, and optimize design and manufacturing processes.
Author and review SOPs, validation protocols, technical reports, and quality plans supporting design history files (DHFs) and risk management files.
Support customer complaint investigations and trend analysis, and collaborate on complaint responses and reporting when required.
Coach and mentor cross-functional teams on advanced quality engineering methods, validation approaches, and compliance practices.
Contribute quality performance data on external partners, critical suppliers, and platform program metrics to Management Review.