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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 patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.
This senior-level Quality Engineer role encompasses various components of the Quality Management System, focusing on product and process quality, supplier quality, design quality, and specific functions within the Quality department to ensure adherence to Quality System Regulations (QSR) and ISO standards. The position emphasizes the safety and efficacy of both components and finished products.
Key Responsibilities
- Deliver comprehensive quality engineering support across all manufacturing, product, and component areas in compliance with relevant procedures, regulations, and standards.
- Oversee supplier management processes, including auditing, evaluating, and approving suppliers of finished products and new materials/components, along with conducting supplier audits.
- Collaborate with engineering and manufacturing teams to develop, review, and approve validation plans, protocols, and reports for products, processes, equipment, and quality/test/inspection methods that are thorough, clearly articulated, and technically robust.
- Lead investigations related to CAPA, complaints, and non-conformance material reports, including root cause analysis, action planning, and implementation.
- Work cross-functionally to establish, implement, and uphold quality and manufacturing procedures and specifications.
- Engage with engineering, supply chain, and suppliers to facilitate component and inspection development, manage component modifications and enhancements, and resolve issues.
- Support the risk management process in line with ISO 14971, which includes developing risk management plans, conducting hazard analyses, FMEAs, and preparing risk management reports throughout all product stages.
- Contribute to the development, support, and execution of general Quality Systems.
- Analyze data to make acceptance decisions and enhance process capability (including DOE, Gage R & R, TMV, IMV, SPC).
- Identify, apply, and update engineering, technical, and regulatory standard requirements pertinent to medical devices.
- Review, initiate, and/or approve change requests.
- Mentor, train, and guide junior staff members.
Qualifications
- Bachelor's degree in Engineering or a related field, accompanied by 5 years of relevant experience.
Preferred Qualifications & Skills
- Master's degree in Engineering or a related discipline.
- 5 years of experience in a quality or engineering role within an FDA or ISO regulated environment.
- 3 years of experience in the medical device sector.
- Experience in assessing and disposing of nonconforming materials/components, conducting CAPA investigations, and technical writing.
- Familiarity with supplier controls, audits, change processing, and corrective actions, as well as receiving inspection.
- Proficient in statistical analysis and software tools.
- Ability to effectively integrate risk management into all activities.
- Capable of independently managing multiple projects, teams, and priorities.
- Experience applying statistical methods to enhance design reliability and process capability.
- Strong verbal and written communication skills, along with analytical and interpersonal abilities.
- Adept at providing technical solutions to complex problems, ensuring they are imaginative, thorough, and aligned with organizational goals.
- Effective team player with a collaborative approach across functions.
- Practical perspective on quality and a cooperative style with colleagues across all business functions.
- Positive attitude towards challenges and a proactive approach to problem-solving.
Equal Opportunity Employer: minority/female/disability/veteran
