Overview
Quality Specialist II – Rye, NY Jobs in New York, NY at New York Blood Center Inc
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.
Key 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
Minimum Qualifications:
Advanced degree in a Computer Science, Math, or Engineering related field and 3 years of relevant experience in the medical device field, or Bachelor’s degree and a minimum of 5 years of relevant experience
Additional Qualifications:
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
Salary Range: $110,000 – 120,000, plus bonus.
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.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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Title: Quality Specialist II – Rye, NY
Company: New York Blood Center Inc
Location: New York, NY
