Sr. Quality Engineer
Location: Eden Prairie, MN
CHF Solutions is an early stage company focused on commercializing the Aquadex FlexFlow® System. Our objective is to improve the quality of life for patients with heart failure and related conditions, such as fluid overload. We are seeking a Sr. Quality Engineer for our Eden Prairie, MN location.
This senior level 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.
- 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.
- Basic statistical knowledge and application to 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.
- Performs other related duties as assigned.
- B.S. or M.S. in Engineering or equivalent discipline
- Minimum of 5 years experience preferably in FDA or ISO regulated environment
- Minimum of 3 years experience in the medical device industry in a quality / engineering role
- 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
- Proficient in incorporating risk management into all activities
- Able to independently manage projects and project teams
- Experience in application of statistical methods to design reliability and process capability
- Working knowledge of statistical analysis/software experience preferred
- 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
- Must be able to handle multiple tasks/projects and manage priorities accordingly
- Practical approach to quality and a partnering style with colleagues in all functions of the business
- Optimistic approach to challenges – “can do” style
How to Apply: If you are interested in applying for this position, email your cover letter and resume to firstname.lastname@example.org. Please indicate the position that you are applying for and the Requisition ID.
Requisition ID: 19-055
CHF Solutions, Inc. is an Equal Opportunity Employer – Minorities/Females/Veterans/Disabled.