HistoSonics
Sr. Supplier Quality Engineer
Plymouth, MN · Senior · Full-time
Sponsorship not specifiedDetected 4 days ago
StatisticsAuditingSupply ChainFDA RegulatoryInternal Audit
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About the role
- This role will work with Design Assurance on risk management updates and the transfer of design documentation into production and will collaborate closely with suppliers, Manufacturing, and Supply Chain to ensure that product meets requirements.
- (What you’ll do): 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 Leads process FMEA (PFMEA) development and ongoing updates 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
Responsibilities
- Supplier Quality Engineer will lead the product assurance activities for commercial production support including inspection, product release, nonconforming material handling, and product complaint analysis.
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 do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #LI-Onsite
Company info
- HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy.
- Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development.
- In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.
- We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.
Equal opportunity
- We are an equal opportunity employer and value diversity at our company.
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This listing is sourced directly from HistoSonics's careers page and normalized into a canonical job model.