Lead Quality Assurance Engineer

1 week ago

Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time
Job Overview

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 facets of the Quality Management System, focusing on product/process quality, supplier quality, design quality, and operational aspects of the Quality department to ensure adherence to Quality System Regulations (QSR) and ISO standards. The position emphasizes maintaining and enhancing the safety and efficacy of both components and finished products.

Key Responsibilities

  • Deliver comprehensive quality engineering support across all manufacturing, product, and component processes, in alignment with relevant procedures, regulations, and standards.
  • Oversee supplier management processes, including auditing, evaluating, and approving suppliers of finished products and new materials/components, while 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 (NCMR), including root cause analysis, action planning, and implementation.
  • Work collaboratively across functions to establish, implement, and sustain quality and manufacturing procedures and specifications.
  • Engage with engineering, supply chain, and suppliers to facilitate component and inspection development, manage component changes and enhancements, and resolve issues.
  • Support the risk management process in accordance with ISO 14971, including the creation of risk management plans, hazard analyses, FMEAs, and 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 through methodologies such as DOE, Gage R & R, TMV, IMV, and SPC.
  • Identify, apply, and update engineering, technical, and regulatory standards applicable to medical devices.
  • Review, initiate, and/or approve change requests as necessary.
  • Mentor, train, and guide junior team 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 and/or engineering capacity within an FDA or ISO regulated environment.
  • 3 years of experience in the medical device sector.
  • Proficiency in assessing and managing nonconforming materials/components, conducting CAPA investigations, and technical writing.
  • Experience with supplier controls, audits, change processing, and corrective actions, along with receiving inspection.
  • Familiarity with statistical analysis and software tools.
  • Expertise in integrating risk management into all operational activities.
  • Able to independently manage multiple projects and priorities effectively.
  • Experience applying statistical methods to enhance design reliability and process capability.
  • Strong verbal and written communication skills, along with analytical and interpersonal abilities.
  • Capable of providing technical solutions to complex problems independently, ensuring solutions are innovative, comprehensive, and aligned with organizational goals.
  • Effective team player with a collaborative approach across functions.
  • Possess a practical mindset towards quality and a cooperative style with colleagues in all business areas.
  • Maintain a positive outlook towards challenges with a proactive approach.

Equal Opportunity Employer: minority/female/disability/veteran

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