Quality Engineer II

Description

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 position is responsible for Quality Engineering and assigned aspects of the Quality Assurance (QA) department operations to assure compliance with the Quality System Regulations (QRS) and ISO 13485 requirements. Coordinate feedback of quality indicators and statistics to business team for use in business decisions. Partner with Manufacturing Engineers in process improvements. Perform, direct, or consult in validations. QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards. Drive investigations, corrective action implementation, and corrective action verification activities assigned to business teams.

POSITION RESPONSIBILITIES

• Maintain Quality Systems: calibration and preventive maintenance system, CAPA, suppliers, training, issues and complaints.
• Maintain Monthly metrics and quality objectives
• Partners with Mfg. Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives.
• Identifies, applies, and updates engineering and technical standards requirements for devices, including standards compliance in product design, manufacture, and labeling.
• Participates in the establishment and implementation of quality specifications, processes, and standards for components, process and finished products.
• Participates in assigned activities aimed at obtaining and maintaining QSR & ISO compliance.
• Performs Receiving Inspection and first articles.
• Performs Final Release activities.
• Participates in the implementation, review and support of non-conforming material control system as assigned. Facilitate the investigation and determination of probable corrective and preventative action for non-conformances.
• Support risk analysis effort by following procedures that address hazard analysis, failure mode & effects criticality actions, and failure analysis.
• Support installation qualifications, operational qualification, performance Qualifications (IQ/OQ/PQ) and Master Validation Quality Plan (MVQP) activities.
• Support product returns process.
• Support methods/procedures for auditing, evaluating and approving suppliers of new materials/components.
• Assists in Internal and External Audit activities.
• Fosters supplier relations to support supplier selection, audits and CAPA issues.
• Maintains current knowledge base on existing and emerging regulations, standards and guidance documents applicable to the business including interpretation, communication of potential impact to the business and assisting in implementing actions to assure compliance.
• Participates in the implementation, review and support of the customer feedback and complaint system as assigned.
• Provide guidance on statistical applications.
• Evaluates and approves Document Change Requests (DCRs) for existing products, monitor design developments for maintaining quality compliance and assists in software engineering, testing, and validation.

WORKING CONDITIONS

• Light work, exerting up to 20lbs. of force or less
• Sit or stand at least 8 hours a day
• Significant work pace & pressure due to deadlines
• Sometimes required to use personal protective equipment

Compensation $80,000-$90,000. We offer excellent benefits including medical, vision, dental and voluntary life insurance. HSA and dependent care FSA. Company paid short and long term disability and life insurance.

Requirements

• Ability to provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives.
• Excellent oral and written communications skills.
• Cross-functionally and an effective team player.
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Working knowledge of appropriate industry standards.
• Experience in application statistical methods to design reliability and process capability.
• Must be able to work in a team environment and exert influence without alienating others.
• Working knowledge of statistical analysis/software experience preferred.
• Experience in application of statistical methods to design reliability and process capability.
• Experience in medical device design and application of test standards.
• Minimum two years quality experience with Class II or Class III medical devices.
• Bachelor's degree in engineering or life sciences.