About the Role:

We are seeking a highly motivated and collaborative Quality Engineer to join our New Product Development (NPD) Quality team. In this role, you will partner with Design Engineering, Test Engineering, Advanced Operations, Manufacturing, Regulatory Affairs, and other cross-functional teams to ensure the successful development, transfer, and commercialization of high-quality medical devices products.

The Quality Engineer will provide leadership and technical expertise in Design Assurance, Risk Management, Design Controls, Process Validation, Usability Engineering, Supplier Quality, and Manufacturing Quality, ensuring compliance with applicable regulatory requirements and quality standards throughout the product lifecycle.

Who We Are Looking For

We are looking for individuals who are:

- Self-directed initiators who take ownership of their work, proactively identify opportunities for improvement, and consistently deliver high-quality results.
- Team-oriented partners who build strong cross-functional relationships and effectively communicate with internal and external stakeholders.
- Analytical problem solvers who investigate root causes, evaluate data-driven solutions, and implement sustainable corrective and preventive actions.

Key Responsibilities

Design Assurance

- Support Design Assurance activities throughout the medical device product development lifecycle.
- Ensure compliance with Design Control requirements in accordance with FDA QSR/QMSR, ISO 13485, and applicable regulatory requirements.
- Support preparation, review, and maintenance of Design History File (DHF) documentation.
- Review product requirements, design outputs, verification, validation, and traceability documentation.
- Support implementation and migration of quality systems and tools (e.g., Jama, Integrity, Matrix, or equivalent).

Risk Management

- Lead and support Risk Management activities in accordance with ISO 14971.
- Develop and maintain Risk Management Files throughout product development and manufacturing transfer.




- Facilitate and review Functional Analysis, Hazard Analysis, dFMEA, pFMEA, and uFMEA.
- Support Critical Quality Attribute (CQA) identification.
- Ensure appropriate risk controls are identified, implemented, verified, and documented.
- Evaluate manufacturing and process risks and ensure effective mitigation throughout the manufacturing lifecycle.

Validation & Usability Engineering

- Support development and maintenance of Usability Engineering Files in accordance with IEC 62366-1.
- Participate in usability studies, formative evaluations, and validation activities.
- Review and approve validation protocols, reports, and statistical analyses.
- Support Design Verification, Design Validation, Process Validation, Software Validation, Computer System Validation, and Sterilization Validation activities as applicable.

Manufacturing & Supplier Quality

- Partner with Advanced Operations and Manufacturing teams during design transfer.
- Ensure manufacturing processes are capable, controlled, and compliant before product launch.
- Support supplier qualification and supplier quality strategies.
- Review supplier validations, PPAP activities, and incoming quality requirements.
- Collaborate with suppliers to ensure components and manufacturing processes meet specified quality requirements.
- Participate in supplier performance monitoring and continuous improvement initiatives.

What you need:

- Bachelors degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or a related engineering discipline.
- Minimum 5-7 years of experience in Quality Engineering, Design Assurance, or Product Development within the medical device industry.
- Experience supporting New Product Development (NPD) in a medical device regulated environment.
- Strong understanding of medical device Design Controls and Risk Management principles.
- Experience preparing and reviewing quality and design documentation.
- Excellent analytical, communication, and organizational skills.
- Demonstrated ability to independently manage priorities and deliver results in cross-functional environments.

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