Quality Sr Engineer I
About The Position
The Senior Quality Engineer supports the design, development, and lifecycle support of medical device hardware for new and existing products, including electrical devices and hardware supporting medical device software. This role works closely with design and cross-functional teams to support new product introductions, maintain hardware design and development documentation, and ensure compliance with applicable quality, regulatory, and industry standards. The position plays a key role in risk management, hardware verification and validation activities, design reviews, equipment qualification, and implementation of hardware changes throughout the product lifecycle.
Requirements
- Must be familiar with all aspects and elements of a quality system including but not limited to management responsibility, resource management, product realization and measurement, analysis and improvement processes.
- Knowledge on aspects of quality assurance techniques such as: inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control
- Experience with creating Quality infrastructure and guidelines for Medical Device Hardware
- Demonstrated technical expertise
- Demonstrates ownership for the integrity of work
- Able to work independently or as part of a team and consider options for completing work
- Strong written and verbal communication skills
- Bachelor’s Degree in Quality or Engineering field, or an equivalent combination of education and experience.
- Must be familiar with Microsoft Office Suite
- Must have minimum of 5 years of experience in Quality Engineering field
- Experience of working in a regulated industry, preferably medical devices.
- Experience working within a quality management system compliant with ISO 13485.
- Strong written and verbal communication skills.
- Proven ability to work effectively across cross-functional teams and influence technical decisions.
Responsibilities
- Partner with design and cross-functional development teams to support quality activities for new product introductions as well as maintenance on existing product lines.
- Lead or contribute to design, implementation, integration, and maintenance for product development projects.
- Maintain product design documentation and ensure it remains current throughout the product lifecycle.
- Support product changes, enhancements, defect corrections, and sustaining engineering activities for released products.
- Lead risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.
- Support verification and validation planning, protocol development, execution, and documentation.
- Participate in design reviews and provide technical guidance to ensure robust, compliant, and maintainable solutions.
- Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.
- Review and approve technical documentation, including, design documents, test protocols, traceability matrices, and change records.
- Provide technical leadership for complex troubleshooting, root cause investigations, and continuous improvement initiatives.
- Mentor engineers and serve as a technical leader across multiple projects and product platforms.
- Support audit, inspection, and regulatory submission readiness activities as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
