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Lead Quality Assurance Engineer
2 months ago
Nuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of individuals experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.
The Principal Design Assurance & Quality Engineer collaborates closely with Marketing, Clinical, Regulatory, R&D, and Operations teams, taking on the critical role of ensuring Quality representation throughout the product lifecycle. This position encompasses responsibilities for product safety and quality across all phases of product and process development, ensuring adherence to design specifications, ISO standards, FDA regulations, and other relevant compliance requirements.
This role requires a full-time, onsite presence at Nuwellis' corporate office.
Key Responsibilities
- Deliver comprehensive quality engineering support during all design and development stages, adhering to applicable procedures, regulations, and standards.
- Review, initiate, and approve change requests related to design verification and validation, risk management, usability, biocompatibility, shelf life, test method validations, equipment qualifications, sterilization, packaging, and labeling.
- Oversee product development processes and associated documentation.
- Manage the organization and maintenance of design history files and related procedures.
- Lead the risk management process in accordance with ISO 14971, including the development of risk management plans, hazard analyses, FMEAs, and risk management reports throughout product development.
- Collaborate with R&D and other functional areas to prepare test plans, analyze data, and implement changes.
- Interpret and contribute to the design and testing of electro-mechanical systems and software.
- Utilize statistical tools for data analysis, acceptance decisions, and process capability improvements.
- Identify and apply engineering, technical, and regulatory standards for medical devices.
- Maintain compliance with Quality System regulations, including ISO 13485 and QSR 21 CFR 820.
- Assist in managing regulatory inspections and audits from certification bodies.
- Develop quality plans to meet corporate and compliance objectives.
- Oversee the receiving and final inspection processes.
- Manage the Material Review Board activities.
- Ensure that Corrective Actions are thorough, effective, and timely.
- Supervise Document and Record Control, Training, CAPA, Change Control, and Feedback Systems.
- Stay informed about existing and emerging regulations, standards, and guidance documents relevant to the industry.
- Act as a Quality liaison with regulatory agencies and the business community as necessary.
- Support the company in maintaining readiness for regulatory inspections.
- Summarize and communicate compliance and feedback information to senior management regularly.
- Oversee supplier quality management to support supplier selection, approval, audits, and CAPA.
- Analyze quality trends and propose strategies to enhance overall quality performance.
Qualifications
- Bachelor's degree in Engineering or a related field.
- A minimum of 10 years of experience in quality and/or design assurance.
Preferred Qualifications
- Master's degree in Engineering or a related discipline.
- ASQ CQE Certification.
- 5 years of experience in the medical device sector.
- 10 years of experience in FDA or ISO regulated environments.
- Experience with software design, verification, and validation.
- Knowledge of biocompatibility, human factors, electrical safety, hardware, and sterilization standards.
- Proficient in managing risk management activities.
- Experience applying statistical methods to enhance design reliability and process capability.
- Strong verbal and written communication, analytical, and interpersonal skills.
- Able to independently devise technical solutions to complex problems.
- Effective in cross-functional collaboration and teamwork.
- Capable of managing multiple tasks and priorities efficiently.
- Practical approach to quality with a collaborative style.
- Able to address inquiries or complaints from customers and regulatory bodies.
- Proficient in MS Excel, Word, and PowerPoint.
Equal Opportunity Employer: minority/female/disability/veteran
