QA Engineer, Medical Devices & Regulatory QMS
$110k - $145kQnovia, Inc.
Qnovia, Inc. is seeking a Quality Assurance Engineer to develop and maintain quality management systems, ensuring compliance with FDA 21 CFR 820 and ISO 13485 regulations. The role is pivotal in advancing products through regulatory approval to commercial production. Responsibilities include supporting design control activities, conducting internal audits, and managing corrective action processes. Candidates should have a Bachelor's degree and at least 5 years of quality assurance experience in medical device manufacturing. The position offers a salary range of $110,000 – $145,000 annually along with equity participation. #J-18808-Ljbffr Qnovia, Inc.
$74k - $104k
Edwards Lifesciences is looking for a Quality Engineer in Irvine, California. In this role, you will ensure compliance with regulatory requirements, oversee new product... ...Preferred candidates will have experience in medical devices and strong project management skills. The...Regulatory- ...Job Description Our F500 Medical Device client has an exciting... ...opportunity for a Senior Software Engineer. Job Summary: We... ...software traceability and regulatory documentation. • Adapt and... ...14971 and internal software QMS SOPs. • Contribute to software...RegulatoryContract workTemporary work
- Position Title:Systems Engineer, Senior Staff Department... ...Engineering Enchannel Medical is redefining the boundaries... ...and release of QMS documentation. In addition... ...with QMS procedures and regulatory standards. Perform IEC... ...Experience in regulated medical devices industries and good...Regulatory
$110k - $145k
...management systems and ensure regulatory compliance across... ...As a Quality Assurance Engineer, you will be... ...continuously improving our QMS, supporting design control... ...processes Review and approve device master records, batch... ...experience in medical device or pharmaceutical...RegulatoryLocal areaFlexible hours- ...Specialist to lead the Quality Management System (QMS) for Global Logistics operations. The role involves ensuring regulatory compliance, managing quality oversight, and... ...degree, 3-5 years of experience in the medical device industry, and proficiency with ERP systems such...Regulatory
$126k - $138k
...California is looking for an experienced QMS Internal Auditor who will play a crucial role in ensuring quality standards and regulatory compliance for our life-saving artificial... ...comprehensive benefits including 401(k) matching, medical, dental, and vision insurance. #J-18808-...Regulatory- Jenavalve Technology Inc is seeking an Engineer, Quality to support transcatheter Heart Valve (THV) manufacturing... ...and have a minimum of 2 years experience in the medical device industry with proficiency in quality and regulatory standards. The position involves working in a...Regulatory
$85k - $118k
A leading medical device company in California is seeking a Quality Engineer II to handle Quality Engineering activities related to product development and support... ...-functional teams, and ensuring compliance with regulatory requirements. Candidates require a Bachelor’s degree...Regulatory- ...Solutions Services, LLC is seeking a Sr Quality Engineer to support product development and cleanroom activities in a medical device environment. The ideal candidate will... ...ensure compliance with quality systems and regulatory standards. A Bachelor's degree in Engineering...Regulatory
- ...involves developing, maintaining, and ensuring compliance with the QMS and EHS management systems. Key responsibilities include... ...continuous improvement, overseeing document control, and ensuring regulatory compliance in quality and EHS. Candidates should have over 5 years...Regulatory
- Electrical Engineer — Medical Device (Onsite/Hybrid — Irvine, CA) Contract Irvine, United States | Posted on 04/16/2026 From development to commercialization... ...our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our...RegulatoryContract work
- ...is seeking a Principal Design Quality Engineer to support the Axonics Integration project... ...while ensuring compliance with regulatory requirements. This hybrid position allows... ...experience in design assurance in the medical device industry. #J-18808-Ljbffr Boston Scientific...Regulatory
- We are seeking a Supplier Quality Engineer to work on a team at our client site in Irvine... ...of launching innovative & life‑saving medical devices. This individual will facilitate... ...understanding of FDA and international regulatory standards for medical devices is preferred...RegulatoryHourly payLocal area
- A leading medical device organization seeks a Senior Software Engineer to modify and manage Android OS for compliance with medical device standards. The ideal... ...risks, implementing OS-level changes, and ensuring regulatory compliance. This is a hybrid position in...RegulatoryContract work
- ...role We are seeking an experienced and driven Software Engineering Manager - Medical Device to lead the development of innovative software solutions... ...will collaborate cross‑functionally with R&D, Quality, Regulatory, Product Management and Business Development teams to...RegulatoryFull timeWork experience placementRemote workFlexible hours
- ENCHANNEL MEDICAL LTD in Irvine is seeking a Staff Hardware Engineer to design and validate complex hardware subsystems for... ...design and validation for medical devices. A bachelor’s degree in... ...along with a keen understanding of regulatory compliance. #J-18808-Ljbffr ENCHANNEL...Regulatory
- ...is seeking a creative thinker for a role focused on product development in the medical device sector. The ideal candidate will have 4-6 years of relevant experience and knowledge of regulatory standards like ISO13485 and FDA regulations. Responsibilities include...Regulatory
$121k - $171k
A leading medical device company in Irvine, California, is seeking a Principal Engineer to lead technical validations in product development for interventional catheter... ...skills, and the ability to drive compliance with regulatory standards. The position offers a competitive...Regulatory$126k - $138k
...seeking an experienced QMS Internal Auditor to... ...directly to the Director of QA & Regulatory Affairs. Key... ...sterilization, and clinical device release. Author audit... ...Bachelor's degree in Engineering, Life Sciences, Biomedical... ...Assurance within the medical device industry....RegulatoryRelocation packageFlexible hoursDay shift$80k - $100k
Masimo Corporation seeks an Engineer II, Software Test in Irvine, CA, to lead medical device testing strategies and automation frameworks. The role requires a Bachelor’s or Master’s degree in a related field and 3+ years of experience in medical device testing. Responsibilities...- ...supporting Global Logistics operations. This role requires maintaining and improving the Quality Management System (QMS) while ensuring compliance with regulatory requirements. The ideal candidate will have a Bachelor's degree and 3-5 years of quality systems experience in...Regulatory
- ...compliance of the Quality Management System (QMS) and Environmental, Health & Safety (EHS... .... The person also trains staff, ensures regulatory compliance for both quality and EHS... ...Report to Global Director of Quality and Engineering on the status of the quality system and...RegulatoryWork at office
$129k - $171k
...Automation team is seeking a Controls Engineer to join our team. The... ...systems architectures, regulatory compliance, and safety buyoffs... ...Experience integrating with MES and QMS Proficient in servo drive and... ...US Roles: Comprehensive medical, dental, and vision plans at...RegulatoryFull timeWork experience placementRelocation package- ...healthcare recruiting firm is seeking a Systems Engineer in Irvine, CA. The ideal candidate will... .... This role involves leading complex medical device development from concept to market while ensuring compliance with regulatory standards. Familiarity with requirement management...Regulatory
- A leading medical technology company is seeking a Systems Engineer in Irvine, California. The role requires a Bachelor's degree in a relevant... ...should have expertise in medical device development and knowledge of regulatory standards such as FDA and ISO 13485. This...Regulatory
$100k - $120k
Masimo Corporation in Irvine, CA is looking for a Senior Engineer, Software Test to lead the design and execution of test strategies for medical device systems. The ideal candidate will develop automated test frameworks and work collaboratively to ensure product quality...- ...Company & Job Overview Diality is a medical device company focused on developing solutions... .... The Clinical Validation Engineer will play a critical role in ensuring that... ...systems, ensuring compliance with regulatory standards and industry best practices....RegulatoryWork at officeFlexible hours
- ...Software Quality Engineer Relevant Experience(in Yrs) - B.S. in Electrical or Computer... .... Provide an expert knowledge of all regulatory requirements and other compliance areas... ...Experience working in a regulated environment (Medical Device, Aerospace, etc.). This includes...Regulatory
$75k - $100k
...Software Quality Engineer II The Software Quality Engineer II supports the development... ...management of software used in medical devices by ensuring quality, compliance, and effective... ...Engineering, Systems Engineering, Regulatory Affairs, and Product Development teams...RegulatoryFull timeWork at officeFlexible hours$90k - $110k
...overseeing the Quality Management System, ensuring compliance with regulatory standards, and leading continuous improvement initiatives in a... ...ranging from $90,000 to $110,000 includes comprehensive benefits such as PTO, medical plans, and more. #J-18808-Ljbffr EmergencyMDRegulatoryFull timeMonday to Friday
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