Quality Engineer – Design Controls [Miami] ON SITE
Job Description
The Quality Engineer – Design Controls is responsible for ensuring that all design and development activities for medical devices comply with applicable regulatory requirements, internal quality standards, and industry best practices. This role partners closely with R&D, Regulatory Affairs, Manufacturing, and Program Management to build robust Design History Files (DHFs), mitigate risk throughout the product lifecycle, and support successful design transfer into manufacturing. The position offers the opportunity to work in a highly innovative medical device environment with strong R&D and product development initiatives that support long-term career growth.
Responsibilities
- Lead and support design control activities to ensure compliance with relevant medical device regulations, standards, and internal quality system requirements.
- Ensure complete and accurate documentation and traceability throughout all phases of product development, including user needs, design inputs, design outputs, verification, validation, and design transfer.
- Own or support the creation, review, and maintenance of Design History File (DHF) documentation such as Design and Development Plans, Risk Management Files, and Design Review records.
- Facilitate risk management activities in alignment with ISO-based practices, including hazard identification, design risk analysis, use-related risk analysis, process risk analysis, and risk–benefit assessments.
- Ensure product and process risks are reduced to acceptable levels, fully documented, and maintained throughout the development lifecycle.
- Work closely with R&D and engineering teams to ensure design documentation meets quality and regulatory expectations and is audit-ready.
- Collaborate with Manufacturing and Operations to support design transfer activities, including PFMEA updates, process validation, and quality planning.
- Participate in design and technical reviews, providing quality and regulatory input and driving resolution of identified issues.
- Review and approve verification and validation (V&V) protocols and reports to ensure technical adequacy, regulatory compliance, and alignment with user needs and design inputs.
- Ensure test methods, acceptance criteria, and sample plans are clearly defined, justified, and validated where applicable.
- Support Engineering Change Orders (ECOs) related to new product development and design modifications, ensuring appropriate assessment and documentation of impacts.
- Maintain audit-ready documentation and support internal and external inspections, including regulatory and quality system audits.
- Contribute to continuous improvement of design control processes, documentation templates, and risk management practices.
- Identify gaps in the Quality Management System related to design and development and propose practical solutions to strengthen compliance and efficiency.
Essential Skills
- 3+ years of experience working with design controls in a Medical Device or life sciences product
- 5+ years of overall engineering experience in product development, quality engineering, or related functions.
- Bachelor’s degree in Engineering or a closely related technical discipline.
- Hands-on experience with Design Control processes, including user needs, design inputs, design outputs, verification, validation, and design transfer.
- Proven experience creating, maintaining, and managing Design History Files (DHF).
- Experience with change control, including supporting and executing Engineering Change Orders (ECOs).
- Practical experience with risk management activities, including FMEA and related risk analysis tools.
- Experience participating in or leading design reviews, with the ability to provide structured quality and regulatory feedback.
- Working knowledge of verification and validation planning, protocol development, and report review.
- Experience with inspection activities and acceptance criteria for components, subassemblies, or finished devices.
- Familiarity with R&D environments and cross-functional collaboration with engineering, manufacturing, and operations teams.
Additional Skills & Qualifications
- Experience applying ISO-based risk management principles to medical device design and development.
- Demonstrated ability to identify process and system gaps and propose improvements within a Quality Management System.
- Strong documentation skills with the ability to produce clear, concise, and compliant technical records.
- Ability to work effectively in a fast-paced, product development–focused organization with multiple concurrent projects.
- Strong analytical and problem-solving skills, with attention to detail in technical and regulatory documentation.
- Effective communication skills for collaborating with cross-functional teams and presenting quality and regulatory considerations in design and technical reviews.
- Comfort working in an environment that