Principal Quality Engineer

Serving as the Technical Quality Lead

Serve as the technical quality lead for Drug Delivery, IVD and Medtech platform projects, providing strategic direction and deep expertise across all phases of product development, from concept through commercialization.

Quality Engineering Authority

Act as the primary quality engineering authority on complex, multi-component assembly projects involving multiple injection molded components, ensuring robust design transfer, validation, and scalability.

Supplier Quality Oversight

Provide quality oversight, supplier controls and technical leadership in managing external consultants, design partners, and contract development/manufacturing organizations (CDMOs), ensuring alignment with internal quality standards, regulatory requirements, and project timelines.

Process Validation Strategies

Drive the development and execution of process validation strategies (IQ/OQ/PQ) for molded and assembled components.

Collaboration and Cross-Functional Work

Collaborate cross-functionally to develop and maintain key process control elements including pFMEAs, Control Plans, acceptance criteria, and inspection documentation tailored to high-precision, regulated products.

Risk-Based Supplier Quality Engineering

Lead risk-based supplier quality engineering activities, including qualification of procured components, supplier audits, incoming inspection strategies, and resolution of non-conformances.

Interface with Suppliers and CDMOs

Interface directly with suppliers and contract manufacturers to establish, monitor, and continuously improve quality agreements, incoming quality metrics, and part qualification strategies.

Technical Root Cause Investigations and CAPA Processes

Lead technical root cause investigations and CAPA processes, ensuring timely closure and compliance with FDA 21 CFR Part 820 and ISO 13485.

Continuous Improvement Initiatives

Drive continuous improvement initiatives through Lean and Six Sigma tools (GR&R, DOE, SPC) to improve yield, reduce variation, and optimize design and manufacturing processes for complex molded and assembled products.

Document Preparation and Review

Author and review SOPs, validation protocols, technical reports, and quality plans to support design history files (DHFs), risk management files.

Customer Complaint Handling

Support customer complaint investigation and trend analysis; collaborate with internal stakeholders and customers on complaint response and reporting when required.

Team Coaching and Mentoring

Provide coaching and mentoring to cross-functional teams on advanced quality engineering methods, validation approaches, and compliance best practices.

Management Review Contributions

Contribute to Management Review by supplying quality performance data related to external partners, critical suppliers, and platform program metrics.

Education and Experience

• Bachelor’s degree in Mechanical, Biomedical, or Industrial Engineering (advanced degree preferred)
• Minimum of 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 in leading quality efforts across cross-functional, multi-organizational teams, including external design, development, and manufacturing partners
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma Black/Green Belt preferred
• Proficiency in Minitab and application of statistical techniques for validation and quality control

Core Competencies

• Subject expertise in design controls, validation (GR&R, IQ/OQ/PQ), risk management (pFMEA, fault tree), statistical process control (SPC), and root cause analysis (5-Why, Fishbone, etc.)
• Strong understanding of FDA, ISO 13485, ISO 14971, 21 CFR Part 820, Good Manufacturing Practices and Good Documentation Practices
• Deep knowledge of injection molding processes, tooling qualification, and metrology
• Strong organizational and communication skills to drive collaboration across internal functions and external partners
• Lead Auditor experience preferred
• Ability to lead technically while influencing without direct authority; self-motivated and resourceful with strategic thinking capabilities
• Analytical thinking and attention to detail, with the ability to manage multiple priorities in a fast-paced environment
• Comprehensive knowledge in blueprint reading, design review and approval
• Requires excellent communication skills, commitment and motivation, and a basic understanding of statistical techniques and ability to interpret SPC charts
• Able to keep neat and organized records and files
• High level of technical expertise in Quality Assurance standards and document control
• Dedication to accuracy, including measurement and documentation requirements
• Excellent oral and written communication skills; must be able to effectively interact with internal and external customers
• Self-starter with initiative requires minimal supervision
• Works with integrity and ethical business practices
• Thorough in completing tasks and focused on quality output
• Team player with a positive, encouraging demeanor
• Able to enforce company policy and values