Senior Quality Engineer (Senior Product Assurance Engineer)
About The Position
HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients. Location: Plymouth, MN (On site) Position Summary: The Sr. Product Assurance Engineer (Quality Engineer) will lead the product assurance activities for commercial production support including inspection, product release, nonconforming material handling, and product complaint analysis. This role will work with Design Assurance on risk management updates and the transfer of design documentation into production and will collaborate closely with Manufacturing and Supply Chain to ensure that product meets requirements.
Requirements
- Bachelor's Degree required
- 5+ years of related experience
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes, and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Experience with risk management, nonconforming material, and complaint handling systems
- Experience with practical application of statistics for product inspection and testing
- Experience with FDA 21 CFR Part 820, ISO 13485 and ISO 14971
Responsibilities
- Leads process FMEA (PFMEA) development and ongoing updates
- Leads product inspection strategy and planning including working with suppliers on purchased product requirements and development of measurement methodologies
- Supports supplier evaluation, auditing, and performance monitoring
- Supports development of in-process and final product testing
- Supports design assurance engineering as needed with risk management activities and review of design documentation including product design requirements and design verification test protocols
- Collaborates with design assurance and manufacturing engineering to ensure that procedures, practices, and documentation comply with applicable standards and regulations
- Supports the transfer of specifications and processes to production during the design transfer phase
- Supports equipment control and process validations
- Reviews Device History Records (DHR) and completes product release
- Leads nonconforming material review and documentation
- Uses knowledge of statistics to support inspection, testing, and process validation activities
- Performs product complaint analysis including associated risk management file reviews and updates
- Acts as Subject Matter Expert (SME) during audits and inspections for product inspection, PFMEA, nonconforming material, and product complaint analysis
- Develops, modifies, and maintains quality system procedures, work instructions, and forms
- Support internal and external audit activities as needed
- Lead CAPA investigations, action planning, and follow-up for assigned CAPAs
- Maintains a safe and clean work environment
- Other duties as assigned by the Director of Product Assurance
Benefits
- We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
