Lead Quality Assurance Engineer
2 weeks ago
Nuwellis, Inc. is a pioneering medical device organization focused on enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.
The Principal Design Assurance & Quality Engineer collaborates closely with various departments including Marketing, Clinical, Regulatory, R&D, and Operations. This role is crucial in ensuring Quality representation throughout the design process, from initial concepts to manufacturing transitions and ongoing product enhancements. The incumbent will be accountable for maintaining product safety and quality at every stage of development, ensuring adherence to design specifications, ISO standards, FDA regulations, and other relevant compliance requirements.
This position necessitates a full-time presence at Nuwellis' corporate office.
Key Responsibilities
- Deliver comprehensive quality engineering support throughout all design and development phases, in line with applicable regulations and standards.
- Evaluate, initiate, and approve change requests related to design verification, validation, risk management, usability, and other critical areas.
- Oversee product development processes and ensure proper documentation and organization of design history files.
- Manage risk assessment processes in accordance with ISO 14971, including the development of risk management plans and hazard analyses.
- Collaborate with R&D and other functional teams to prepare test plans and conduct data analysis.
- Utilize statistical methodologies to analyze data and enhance process capabilities.
- Maintain compliance with Quality System Regulations (QSR), ISO 13485, and EU MDR standards.
- Support regulatory inspections and audits, ensuring the company is prepared for assessments.
- Develop and implement quality plans to meet corporate objectives.
- Supervise the Material Review Board and ensure effective corrective actions are taken.
- Keep abreast of emerging regulations and standards relevant to the medical device industry.
Qualifications
- Bachelor's degree in Engineering or a related field.
- A minimum of 10 years of experience in quality assurance or design assurance roles.
Preferred Skills
- Master's degree in Engineering or a similar discipline.
- ASQ CQE Certification.
- Experience in the medical device sector, particularly within FDA or ISO regulated environments.
- Familiarity with software design and validation processes.
- Strong analytical and communication skills, with the ability to provide technical solutions to complex problems.
- Proficiency in Microsoft Office Suite.
Nuwellis, Inc. is an Equal Opportunity Employer, welcoming applicants from diverse backgrounds.
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