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Lead Quality Assurance Engineer

2 months 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 dealing with 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 and process quality, supplier quality, design quality, and operational elements within the Quality department to ensure adherence to Quality System Regulations (QSR) and ISO standards. The emphasis is on maintaining and enhancing the safety and efficacy of both components and finished products.

Key Responsibilities

  • Deliver comprehensive quality engineering support across all manufacturing and product domains, in line with applicable 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 endorse product, process, equipment, and quality/test/inspection validation plans, protocols, and reports that are thorough, well-articulated, and technically robust.
  • Lead investigations related to CAPA, complaints, and non-conformance material reports (NCMR), focusing on 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 for the development of components and inspection processes, addressing component modifications and enhancements, and resolving issues.
  • Support the risk management process in compliance with ISO 14971, including the development 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, make acceptance decisions, and enhance process capability through various methodologies (DOE, Gage R & R, TMV, IMV, SPC).
  • Identify, apply, and update engineering, technical, and regulatory standards applicable 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 capacity within an FDA or ISO regulated environment.
  • 3 years of experience in the medical device sector.
  • Experience in assessing and managing nonconforming materials/components, conducting CAPA investigations, and technical writing.
  • Familiarity with supplier controls, audits, change processing, and corrective actions, along with receiving inspection processes.
  • Proficient in statistical analysis and software applications.
  • Ability to integrate risk management into all operational activities.
  • Capable of independently managing multiple projects 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 solutions are innovative, comprehensive, and aligned with organizational goals.
  • Effective team player with a collaborative approach across functions.
  • Practical perspective on quality, fostering a cooperative relationship with colleagues across all business functions.
  • Positive attitude towards challenges, demonstrating a proactive approach.

Equal Opportunity Employer: minority/female/disability/veteran