Senior Quality Engineer

Nuwellis, Inc. is a medical device company dedicated to transforming the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy.
This senior level Quality Engineer position is responsible for multiple elements across the Quality Management System including product/process quality, supplier quality, design quality, and assigned aspects of the Quality department operations to assure compliance with the Quality System Regulations (QRS) and ISO 13485. This position is focused on the products and processes to maintain and improve the safety and effectiveness of components and finished goods.
This is an onsite position, requiring a full-time in-person presence at Nuwellis' corporate office in Eden Prairie, MN.
ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide effective quality engineering support in all aspects of manufacturing, product, and component support in accordance with all applicable procedures, regulations and standards.
• Manage supplier control processes and procedures for auditing, evaluating and approving suppliers of finished product and new materials/components, and perform supplier audits.
• Partner with engineering and manufacturing to create, review & approve product, process, equipment, and quality/test/inspection method validation plans/protocol and reports that are comprehensive, clearly written and technically sound for execution.
• Lead CAPA/Complaint/NCMR investigations; root cause analysis, action planning, and implementation.
• Work cross-functionally to establish, implement, and maintain quality/manufacturing procedures and specifications.
• Partner with engineering, supply chain, and suppliers for component and inspection development, component changes and improvements, and issue investigation and resolution.
• Support the risk management process in accordance with ISO 14971, including risk management plans, hazard analyses, FMEAs, and risk management reports, throughout all product phases.
• General Quality Systems development, support, and execution.
• Analyze data, make acceptance decisions, and improve process capability (DOE, Gage R & R, TMV, IMV, SPC).
• Identify, apply, and update engineering, technical, and regulatory standard requirements for medical devices.
• Review, initiate, and/or approve change requests.
• Mentor, train, and coach junior staff members.

Requirements
MINIMUM QUALIFICATIONS

• Bachelor's degree in Engineering or other relevant discipline and 5 years of related experience.

PREFERRED QUALIFICATIONS & COMPETENCIES

• Master's degree in Engineering or related discipline.
• 5 years of experience in a quality and/or engineering role in an FDA or ISO regulated environment.
• 3 years of experience in the medical device industry.
• Experience in nonconforming material/component assessment and disposition, CAPA investigations, technical writing.
• Experience with supplier controls, supplier audits, supplier change processing, supplier corrective actions, receiving inspection.
• Working knowledge of statistical analysis/software experience.
• Proficient in incorporating risk management into all activities.
• Able to independently manage multiple projects, project teams and priorities.
• Experience in application of statistical methods to design reliability and process capability.
• Effective verbal and written technical communication, analytical, and interpersonal skills.
• Able to independently provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives.
• Able to work cross-functionally and contribute as an effective team player.
• Practical approach to quality and a partnering style with colleagues in all functions of the business.
• Optimistic approach to challenges - "can do" style.

Equal Opportunity Employer: minority/female/disability/veteran