HistoSonics, Inc.
Overview
Senior Quality Engineer (Senior Product Assurance Engineer) at HistoSonics, Inc. Location: Plymouth, MN (On site). Base pay range:
$110,000.00/yr - $120,000.00/yr . This role leads the product assurance activities for commercial production support including inspection, product release, nonconforming material handling, and product complaint analysis. The position collaborates with Design Assurance on risk management updates and the transfer of design documentation into production, and works closely with Manufacturing and Supply Chain to ensure products meet requirements. Responsibilities
Lead process FMEA (PFMEA) development and ongoing updates Lead product inspection strategy and planning, including working with suppliers on purchased product requirements and development of measurement methodologies Support supplier evaluation, auditing, and performance monitoring Support development of in-process and final product testing Support design assurance engineering with risk management activities and review of design documentation including product design requirements and design verification test protocols Collaborate with design assurance and manufacturing engineering to ensure procedures, practices, and documentation comply with applicable standards and regulations Support the transfer of specifications and processes to production during the design transfer phase Support equipment control and process validations Review Device History Records (DHR) and complete product release Lead nonconforming material review and documentation Apply statistics knowledge to support inspection, testing, and process validation activities Perform product complaint analysis including associated risk management file reviews and updates Act as Subject Matter Expert (SME) during audits and inspections for product inspection, PFMEA, nonconforming material, and product complaint analysis Develop, modify, and maintain 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 Maintain a safe and clean work environment Other duties as assigned by the Director of Product Assurance Qualifications
Minimum: Advanced degree in Computer Science, Math, or Engineering with 3 years of relevant medical device experience; or Bachelor’s degree with a minimum of 5 years of relevant experience Additional Qualifications
Ability to work in a team and independently in a fast-paced, changing environment Strong verbal and written communication skills across multiple levels Ability to multitask, prioritize, and meet deadlines Strong organizational and follow-up skills with attention to detail Experience with risk management, nonconforming material, and complaint handling systems Experience with practical statistics for product inspection and testing Experience with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 Salary & Benefits
Salary Range: $110,000 - $120,000, plus bonus. Benefits: Comprehensive benefits package for full-time employees, including 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance and Engineering Industries: Medical Equipment Manufacturing We are not currently including external postings or unrelated job board updates in this refined description.
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Senior Quality Engineer (Senior Product Assurance Engineer) at HistoSonics, Inc. Location: Plymouth, MN (On site). Base pay range:
$110,000.00/yr - $120,000.00/yr . This role leads the product assurance activities for commercial production support including inspection, product release, nonconforming material handling, and product complaint analysis. The position collaborates with Design Assurance on risk management updates and the transfer of design documentation into production, and works closely with Manufacturing and Supply Chain to ensure products meet requirements. Responsibilities
Lead process FMEA (PFMEA) development and ongoing updates Lead product inspection strategy and planning, including working with suppliers on purchased product requirements and development of measurement methodologies Support supplier evaluation, auditing, and performance monitoring Support development of in-process and final product testing Support design assurance engineering with risk management activities and review of design documentation including product design requirements and design verification test protocols Collaborate with design assurance and manufacturing engineering to ensure procedures, practices, and documentation comply with applicable standards and regulations Support the transfer of specifications and processes to production during the design transfer phase Support equipment control and process validations Review Device History Records (DHR) and complete product release Lead nonconforming material review and documentation Apply statistics knowledge to support inspection, testing, and process validation activities Perform product complaint analysis including associated risk management file reviews and updates Act as Subject Matter Expert (SME) during audits and inspections for product inspection, PFMEA, nonconforming material, and product complaint analysis Develop, modify, and maintain 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 Maintain a safe and clean work environment Other duties as assigned by the Director of Product Assurance Qualifications
Minimum: Advanced degree in Computer Science, Math, or Engineering with 3 years of relevant medical device experience; or Bachelor’s degree with a minimum of 5 years of relevant experience Additional Qualifications
Ability to work in a team and independently in a fast-paced, changing environment Strong verbal and written communication skills across multiple levels Ability to multitask, prioritize, and meet deadlines Strong organizational and follow-up skills with attention to detail Experience with risk management, nonconforming material, and complaint handling systems Experience with practical statistics for product inspection and testing Experience with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 Salary & Benefits
Salary Range: $110,000 - $120,000, plus bonus. Benefits: Comprehensive benefits package for full-time employees, including 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance and Engineering Industries: Medical Equipment Manufacturing We are not currently including external postings or unrelated job board updates in this refined description.
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