Quality Engineer (Development)
Quality Engineer - Product Development (Medical Device)
Position Summary
We are seeking a Quality Engineer to support the development and commercialization of innovative medical devices. This role will partner closely with R&D, Regulatory Affairs, Clinical, Manufacturing, and Operations teams to ensure quality is designed into products from concept through commercialization. The successful candidate will play a key role in design controls, risk management, verification and validation, and new product introduction activities.
This position is heavily focused on product development quality engineering rather than production support and is ideal for an engineer who enjoys working on innovative technologies, solving technical challenges, and influencing product design decisions.
Key Responsibilities
Product Development Quality
- Serve as the Quality Engineering representative on cross-functional product development teams.
- Ensure compliance with design control requirements throughout the product development lifecycle.
- Partner with R&D to establish design inputs, quality requirements, and acceptance criteria.
- Participate in design reviews and provide independent quality assessments.
- Develop, review, and approve Design History File (DHF) documentation.
- Support design transfer activities and product commercialization efforts.
Risk Management
- Lead and facilitate risk management activities in accordance with ISO 14971.
- Develop and maintain risk management files.
- Facilitate Design FMEA (DFMEA), Process FMEA (PFMEA), hazard analyses, and risk assessments.
- Ensure risk controls are identified, implemented, and verified.
Verification & Validation
- Review and approve test strategies, protocols, and reports.
- Support development and execution of:
- Design Verification testing
- Design Validation activities
- Test Method Validation (TMV)
- Process Validation (IQ/OQ/PQ)
- Analyze test data and ensure results support regulatory and quality requirements.
- Collaborate with engineering teams to resolve verification and validation challenges.
New Product Introduction (NPI)
- Support quality deliverables associated with new product development and product launches.
- Ensure manufacturing readiness through collaboration with Manufacturing Engineering and Operations teams.
- Review control plans, inspection methods, manufacturing specifications, and process controls.
- Support process characterization and qualification activities.
Quality Systems & Compliance
- Ensure compliance with FDA Quality System Regulations, ISO 13485, and applicable regulatory requirements.
- Support internal and external audits.
- Participate in CAPA investigations, nonconformance reviews, and root cause analyses.
- Drive continuous improvement initiatives using data-driven decision making and risk-based methodologies.
Required Qualifications
- Bachelor's degree in Engineering or related technical discipline.
- 3+ years of Quality Engineering experience within the medical device industry.
- Experience supporting product development, R&D, or new product introduction initiatives.
- Strong knowledge of:
- Design Controls
- Design History Files (DHF)
- Risk Management (ISO 14971)
- DFMEA and PFMEA
- Verification and Validation methodologies
- Test Method Validation
- Process Validation (IQ/OQ/PQ)
- Root Cause Analysis and CAPA
- Knowledge of FDA and ISO 13485 requirements.
- Strong technical writing, problem-solving, and project management skills.
- Ability to work effectively within a cross-functional product development environment.
FAQs
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