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Lead Quality Assurance Engineer
2 months ago
Nuwellis, Inc. is a pioneering medical device organization focused on enhancing the lives of patients dealing with fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.
The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and Operations. This role is crucial for ensuring Quality representation on teams that facilitate initial design, transition to manufacturing, and enhancements in processes and products. The individual in this position is accountable for maintaining product safety and quality throughout all phases of product and process development, ensuring adherence to design specifications, ISO standards, FDA regulations, and other relevant compliance requirements.
This role necessitates a full-time, onsite presence at Nuwellis' corporate office.
Key Responsibilities
- Deliver comprehensive quality engineering support throughout the design and development phases, in alignment with all relevant procedures, regulations, and standards.
- Review, initiate, and approve change requests related to design verification & validation, risk management, usability, biocompatibility, shelf life, test method validations, equipment qualifications, sterilization, packaging, and labeling.
- Oversee product development processes and related procedures.
- Manage the organization and maintenance of design history files and associated deliverables.
- Administer the risk management process in compliance with ISO 14971, including risk management plans, hazard analyses, FMEAs, and risk management reports across all product development stages.
- 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 relevant to medical devices.
- Maintain the Quality System, ensuring compliance with ISO 13485, EU MDR 2017/745, and QSR 21 CFR 820.
- Assist in managing regulatory inspections and audits from certification/accreditation bodies.
- Develop quality plans to meet corporate and compliance objectives.
- Oversee the receiving and final inspection processes.
- Manage the Material Review Board.
- Ensure that Corrective Actions are thorough, effective, and timely.
- Supervise Document and Record Control, Training, CAPA, Change Control, and Feedback and Complaint Systems.
- Stay informed on existing and emerging regulations, standards, and guidance documents applicable to the industry.
- Act as a Quality liaison with government 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 to facilitate supplier selection, approval, audits, and CAPA.
- Identify 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 an FDA or ISO regulated environment.
- Experience with software design, verification, and validation.
- Familiarity with biocompatibility, human factors, electrical safety, hardware, and sterilization standards.
- Proficient in managing risk 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, ensuring alignment with organizational goals.
- Capable of working cross-functionally and contributing effectively as a team player.
- Ability to manage multiple tasks/projects and prioritize effectively.
- Practical approach to quality with a collaborative style.
- Competent in responding to inquiries or complaints from customers and regulatory agencies.
- Proficient in MS Excel, Word, and PowerPoint.
Equal Opportunity Employer: minority/female/disability/veteran
