Principal Quality Engineer (ISO 13485)

We are seeking a highly experienced and technically skilled Principal Quality Engineer to lead critical quality engineering activities for Drug Delivery, IVD and Medtech platform projects. This role is responsible for driving the development, implementation, and oversight of quality systems and process controls across complex programs involving multiple injection molds, procured components, and external design and manufacturing partners. The Principal Quality Engineer will serve as a subject matter expert in regulatory compliance (e.g., ISO 13485, FDA QSR), validation strategy, and supplier quality, ensuring robust risk management and alignment with customer and regulatory expectations. This position plays a key leadership role in achieving quality objectives, advancing continuous improvement initiatives, and ensuring successful product development and commercialization.

Essential Job Functions and Responsibilities :

• 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.
• 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.
• 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.
• Drive the development and execution of process validation strategies (IQ/OQ/PQ) for molded and assembled components.
• 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.
• Lead risk-based supplier quality engineering activities, including qualification of procured components, supplier audits, incoming inspection strategies, and resolution of non-conformances.
• Interface directly with suppliers and contract manufacturers to establish, monitor, and continuously improve quality agreements, incoming quality metrics, and part qualification strategies.
• Act as quality liaison during design and technical reviews with internal and external partners, providing subject matter expertise on quality engineering considerations for drug combination products and devices.
• Conduct and 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 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.
• Author and review SOPs, validation protocols, technical reports, and quality plans to support design history files (DHFs), risk management files.
• Support customer complaint investigation and trend analysis; collaborate with internal stakeholders and customers on complaint response and reporting when required.
• Provide coaching and mentoring to cross-functional teams on advanced quality engineering methods, validation approaches, and compliance best practices.
• Contribute to Management Review by supplying quality performance data related to external partners, critical suppliers, and platform program metrics.

Education and/or 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.
• Ability to enforce company policy and values.

Physical Demands :

• Able to work on-site 5 days a week
• Light to moderate physical effort required
• Must be able to lift to 35 pounds
• Regularly required to sit or stand
• Regularly required to use stairs
• Standing, walking, bending, and sitting