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.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the QA Engineer, Medical Devices & Regulatory QMS in Newport Beach, CA vacancy
$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- ...in Huntington Beach, California, is seeking a Manufacturing Engineer IV. This role leads the design and improvement of manufacturing... ...8 years of experience in engineering and a background in medical device regulations, you will also mentor junior engineers and manage...Suggested
- .... in Huntington Beach, CA, is seeking a Senior Manufacturing Engineer to own electrical manufacturing processes (PCBA, harness, controller... ...with strong ISO 13485 and FDA QSR familiarity; direct experience with Class III medical devices is required. #J-18808-Ljbffr BiVACOR Inc.Suggested
- An innovative and rapidly growing medical device organization is seeking a Senior Software Quality Engineer to play a critical role in ensuring the quality, compliance... ...teams across product development, quality, regulatory, and engineering while helping bring life-changing...Regulatory
Real Staffing Group
Irvine, CA3 days ago $146k - $194k
...Automation team is seeking a Senior Controls Engineer to join our team. The Manufacturing... ...standards for control systems architectures, regulatory compliance, and safety buyoffs Integrate... ...Experience integrating with MES and QMS Preferred Qualifications UL508A MTR Certification...RegulatoryFull timeWork experience placementImmediate startShift work- BiVACOR is seeking a Field Clinical Engineer to support the world’s first Total Artificial Heart across implant sites in the US and abroad... ...teams, ICU staff, and biomedical engineers to ensure safe device operation from implant through follow-up. Responsibilities include...
$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$155k - $169.99k
...in Huntington Beach is seeking a Senior Manager for Quality Engineering to lead their quality organization in developing a cutting-edge... ...is a high-impact role requiring extensive experience in the medical device sector, particularly with Class III Active Implantable...- ...in Costa Mesa, CA seeks a Sr. Specialist, QA Batch Review to lead complex batch record reviews ensuring FDA/EMA compliance and QMS conformance. This senior SME mentors junior... ..., and collaborate with manufacturing, regulatory affairs, and R&D to embed quality throughout...Regulatory
$110.7k - $218.3k
...Operations & Risk Our Deloitte Regulatory, Risk & Forensic team... ...how Commercial and Medical activities and related... ...and medical device Regulatory Affairs and... ...integration activities for QA/RA, including Day 1 readiness... ...quality management system (QMS) and regulatory...RegulatoryLocal areaDeloitte
Costa Mesa, CA3 days ago$85k - $123k
...Quality Assurance Engineer The Quality Assurance Engineer is responsible... ...within a regulated medical device environment. This role provides... ...manufacturing operations. The QA Engineer serves as a... ...established specifications, regulatory requirements, and quality standards...RegulatoryWork at officeNihon Kohden Orange Med
Santa Ana, CA2 days ago$114k - $152k
...and contract manufacturing of medical products. Oversees the... ...Participates in the reviewing of engineering designs to contribute quality... ...knowledge of the application of regulatory requirements for low-risk and... ...and improve Software QMS processes. Pay range: $114,0...RegulatoryContract workRemote work$130k - $200k
...experience in SUD and Mental Health treatment environments and a deep understanding of outreach, census growth, clinical operations, and regulatory requirements. Key Responsibilities 1. Operational Leadership Oversee multiple facilities with program directors...RegulatoryAKUA BEHAVIORAL HEALTH INC
Newport Beach, CA16 days ago- Regulatory Affairs & Quality Associate Location: Huntington Beach,... ...safe, reliable, and innovative medical devices that improve patient... ...Prepare and maintain Usability Engineering / Human Factors Reports and... ...Quality Management System (QMS). Review and approve product...RegulatoryFull timeWork at office
- ...solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs,... ...clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control... .... Job Title: Electrical Test Engineer II Job Location: Irvine, CA Job Duration...RegulatoryContract work
- ..., land, and sea. We combine comprehensive analysis, engineering, and program execution capabilities to deliver mission... ...records comply with applicable aerospace, customer, regulatory, and Quality Management System (QMS) requirements.Partners with Engineering and...RegulatoryPermanent employmentFor contractors
Karman Space & Defense
Huntington Beach, CA3 days ago $155k - $169.99k
...role at the intersection of quality engineering strategy and clinical-stage medical device development. As Senior Manager,... ...quality, supplier controls, and regulatory compliance — you will define the... ...programs, drive enterprise-level QMS maturity, and serve as a senior executive...RegulatoryRelocation packageDay shift$146k - $194k
...’s Manufacturing Automation team is seeking a Senior Controls Engineer to join our team. The Manufacturing Automation team is responsible... ...enforce internal standards for control systems architectures, regulatory compliance, and safety buyoffsIntegrate internal and external...RegulatoryFull timeWork experience placementImmediate startShift workAnduril Industries
Costa Mesa, CA4 days ago- ...seeking an experienced Validation Engineer to support validation... ...development within a regulated medical device environment. The ideal... ...validation activities meet regulatory, quality, and business requirements... ...accordance with GMP/GDP and QMS requirements. Education &...Regulatory
Katalyst Healthcares & Life Sciences
Irvine, CA4 days ago - .... in Huntington Beach, CA is hiring a Regulatory Affairs & Quality Associate to ensure... ...regulatory and quality compliance for our medical device portfolio. The role demands a... ...while working closely with Quality, R&D, Engineering, and Manufacturing teams. #J-18808-Ljbffr...Regulatory
- ...delegated IPAs, and vendors to support timely claims issue resolution. Support claims-related system implementations, testing, regulatory updates, process improvements, and departmental projects. Draft and coordinate professional communications related to provider...RegulatoryWork at officeImmediate start
Impresiv Health
Huntington Beach, CA3 days ago $80k - $105k
...Description Job Description Field Service Engineer (Remote) Columbus, OH (Regional... ..., patient monitoring, and related medical device systems within hospital and clinical environments... ...policies, quality standards, and regulatory requirements. Maintain professional...RegulatoryContract workRemote work$95k - $115k
...Number: 194806Apply: JobAs a Manufacturing Engineer, you will independently lead... ...processes comply with quality systems and regulatory requirements.Continuous ImprovementIdentify... ...in Mechanical EngineeringExperience in medical device, regulated manufacturing, or highly...RegulatoryFlexible hoursPhillips-Medisize
Costa Mesa, CA1 day ago- ...Senior Engineer, R&D Sustainment (IHFM) - Irvine, CAJoin the Implantable... ...of Class III implantable medical devices. This on-site role focuses... ..., quality, reliability, and regulatory compliance.Key... ...with ISO 13485, ISO 14971, FDA QMS regulations, and medical device...Regulatory
Real Staffing Group
Irvine, CA1 day ago $121.2k - $166.7k
...As a Manufacturing Engineer III, you will be responsible for leading... ..., and in compliance with regulatory standards and qualify management... ...capacity. Management of QMS systems, including updates to... ...experience, preferably in medical device manufacturing. Past experience...RegulatoryWork at officeBio-Rad Laboratories
Irvine, CA5 days ago$19 per hour
...Job Title: Medical Device Assembler Location: Irvine, CA Hours: 5:00 AM to 1:30 PM | Pay: $19 per hour... ...and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Requirements: High school...RegulatoryHourly payAxelon
Irvine, CA4 days ago$220k - $292k
...technical leadership across Anduril’s Test Operations, Test Engineering, and Test Automation teams. In this role, you will lead end to... ...strong organizational foundation focused on safety standards, regulatory adherence, and performanceEnsure compliance with FAA, FCC,...RegulatoryFull timeWork experience placementImmediate startAnduril Industries
Costa Mesa, CA2 days ago$160k - $200k
...quality, and cross-functional execution. In partnership with Engineering, Supply Chain, Program Management, Sales, and Operations, the... ...commitments are achieved. Ensure compliance with applicable regulatory requirements, company policies, export control regulations,...RegulatoryPermanent employmentImmediate startElevate Aircraft Seating
Huntington Beach, CA6 days ago- ...Description: Quality Management System (QMS) Develop, implement, and maintain the... ...assessments Work closely with Procurement and Engineering to evaluate suppliers for quality, lead... ...(SCARs) and containment activities. Regulatory & Safety Compliance Support...Regulatory
FirstElement Fuel
Santa Ana, CA15 days ago $150k - $195k
...Industries is seeking a Senior Automation Engineer, Factory Software to develop the software... ...connecting manufacturing equipment, edge devices, MES, SCADA, historians, and... ...manufacturing systems including PLM, MES, QMS, factory equipment, and data platforms.Build...Permanent employmentWork experience placementWork at officeLocal areaWeekend workMach Industries
Huntington Beach, CA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to QA Engineer, Medical Devices & Regulatory QMS. Be the first to apply!
Related searches
- medical device Newport Beach, CA
- regulatory contract Newport Beach, CA
- regulatory law Newport Beach, CA
- food regulatory Newport Beach, CA
- regulatory engineer Newport Beach, CA
- regulatory Newport Beach, CA
- qa technician Newport Beach, CA
- vice president quality assurance Newport Beach, CA
- quality assurance representative Newport Beach, CA
- quality assurance Newport Beach, CA