Regulatory QA Technician - Medical Devices
The Argen Corporation
The Argen Corporation is hiring a Quality Assurance Technician in San Diego, CA. This full-time role involves maintaining quality systems, preparing regulatory documents, ensuring compliance, and supporting product development. Candidates should have a Bachelor’s degree in Quality Engineering or related field, with technical knowledge in ISO standards being preferred. Argen offers a wealth of benefits including health plans, a 401k with employer match, and various discounts, ensuring the well-being and growth of its employees. #J-18808-Ljbffr The Argen Corporation
- ...degree in Quality Engineering or a related field, with a thorough understanding of regulations impacting medical devices. Responsibilities include preparing regulatory documentation, supporting product development, participating in audits, and continuous improvement of...RegulatoryMedical device
$149k - $248.3k
...California. This role encompasses leading software quality assurance and ensuring compliance with regulatory standards. With at least 7 years of experience in software QA and 5 years in leadership, you will manage the software development lifecycle and mentor QA teams....RegulatoryMedical deviceRemote job- Purpose The Production Technician under direct supervision, completes the manufacturing... ...accuracy. Ability to follow SOPs and regulatory guidelines with precision. Proficiency... .... Experience in Biotechnology/Medical Device preferred. Associate’s degree (AA) in...RegulatoryMedical deviceWork at officeWeekend work
$70k - $82k
...readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA).... ...improvements. ~ Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain... ...experience within biopharma, biotech, medical devices, or related regulated industry....RegulatoryMedical device$270k - $300k
...Executive Director of GMP Quality Assurance (QA) to serve as a senior quality leader... ...readiness for GMP internal audits and regulatory inspections Provide strategic oversight... ...pharmaceutical, biotechnology, and/or medical device environments, with deep understanding of...RegulatoryMedical device- ...Location: Onsite in San Diego, CA The QA Complaint Intake Specialist / QA... ...documentation, follow-up, and verification of medical device complaints associated with the product... ...availability for evaluation ? Potential regulatory reporting considerations...RegulatoryMedical device
$175k - $215k
...launch. The ideal candidate brings hands-on QA and Quality Systems experience, deep... ...ensuring alignment with company objectives and regulatory standards Develop, implement, and... ...(pharmaceutical, biotechnology, or medical devices) ~ Direct experience in cell and gene...RegulatoryMedical deviceWork at office$100k - $120k
...About the role: The Quality Assurance (QA) Specialist is responsible for... ...maintain quality systems that meet applicable regulatory standards such as ISO 9001, GAMP 5, EU GMP... ...in pharmaceutical, biotech, or medical device industries. Compensation and Benefits...RegulatoryMedical deviceLocal areaFlexible hours$87k - $145k
...Regulations 21CFR Part 820 and international quality systems and medical device standards (e.g. ISO 13485). Certified or trained to perform... ...this schedule. May attend and support internal audits by regulatory and other outside agencies. You will establish and maintain...RegulatoryMedical deviceWork at officeWorldwideHome officeShift work$24 - $28 per hour
...process. Quality Assurance Technician Full Time San Diego, CA... ...in the preparation of regulatory documentation for... ...documentation including device licenses, device listings... ...with guidance of QA Management, including internal... ...regulations impacting medical devices Team-oriented...RegulatoryMedical deviceHourly payFull timeFor contractors$72k - $100k
...professional to manage product complaints, ensuring compliance with regulatory standards. The role involves investigating complaints,... ...degree and at least 5 years of experience in the pharmaceutical/medical device industry. This position offers robust benefits and a...RegulatoryMedical device$205.1k - $307.7k
...quality standards across product development. Candidates should have over 20 years of experience in software quality within the medical device industry and a deep understanding of IEC 62304 and SaMD frameworks. The estimated salary range is $205,100 - $307,700,...RegulatoryMedical device$169.8k - $280.3k
...purpose BD is one of the largest global medical technology companies in the world.... ...representative for notified bodies and liaison with regulatory authorities and customers, by hosting... ...in the pharmaceutical and/or medical device industries, with three (3) years...RegulatoryMedical deviceFor contractorsWork at officeLocal areaRemote workWorldwideShift work- A global medical technology company in San Diego is seeking a Director of Quality Engineering to lead the quality engineering function. This role involves ensuring that medical devices meet regulatory compliance and safety standards, mentoring a team of engineers, and developing...RegulatoryMedical device
$86k - $115k
...issues, or continuous improvement initiatives. Participate in regulatory agency and third-party inspections by supporting inspection... ...Qualifications Education and Experience Five (5) years of relevant Medical Device or similar industry experience required BS degree in...RegulatoryMedical deviceWork at officeLocal areaFlexible hours$149k - $248.3k
...assurance, including managing and mentoring the QA team. This role works closely with cross... ...comply with U.S. and international regulatory standards. Additionally, this position... ...years in software QA or development for medical devices, including 5 years leading high-...RegulatoryMedical deviceWork at officeWorldwideHome office$130k - $150k
...Software Design Quality Assurance Engineer in San Diego, CA for our client, supporting software quality, regulatory compliance, and design assurance within a medical device environment. This role focuses on ensuring compliance with standards such as IEC 62304 and FDA...RegulatoryMedical deviceMonday to Friday- As a Quality Assurance Specialist 3 within our Regulatory and Quality - Diagnostics team, you will be integral to ensuring the highest... ...quality improvement processes. Experience with MediaLab and medical device quality system regulations is a plus. Skills Demonstrated...RegulatoryMedical device
$85k - $105k
...Responsibilities: Support Quality Assurance (QA) Batch Record Review, Product... ...molecule, biologics, and device products Perform QA Batch... ...internal, external, mock, and regulatory audits Provide quality and... ...management support for pharmaceutical, medical device, or combination...RegulatoryMedical deviceFull timeContract workTemporary workRemote workShift work- ResMed Inc is seeking a Compliance Engineer in San Diego, California, focusing on enhancing patient outcomes through compliance with regulatory standards. You will collaborate with engineering teams, act as a subject matter expert in audits, and ensure that technical...RegulatoryMedical device
- ...maintaining the Quality Management System in compliance with regulatory requirements like ISO 13485 and FDA standards. The ideal candidate... ...a deep understanding of quality systems and relevant experience in the medical device industry. #J-18808-Ljbffr Ignite Human CapitalRegulatoryMedical device
$100k - $130k
...legal obligations Supervise inspectors, technicians and other staff and provide guidance... ...with industry best practices and regulatory requirements Requirements Minimum Bachelor... ...principles and practices in the medical device industry Excellent communication and...RegulatoryMedical device$200k - $240k
...GMP requirements. Working closely with executive leadership, Regulatory Affairs, Shionogi Quality partners, CMOs, and external consultants... ...of proven successes in research and the pharmaceutical, medical device, and biotechnology industries. Experience in global quality systems...RegulatoryMedical deviceFull timeContract workLocal area$135k - $165k
...Quality Engineer to ensure compliance and excellence in IVD and medical device products. In this individual-contributor role, you will... ...maintain quality management systems, support audits, and ensure regulatory compliance. This role offers a competitive salary range of $1...RegulatoryMedical device$123k - $143.4k
...Engineer in San Diego, CA. The candidate will support the Design Assurance process during the development of new medical devices, ensuring compliance with regulatory requirements and company policies. Responsibilities include risk management deliverables, testing data...RegulatoryMedical device- ...investigations and corrective actions with regulatory requirements, and partners cross-... ...committee. Facilitate discussions with medical affairs and other relevant functions to... ...years of progressive experience in medical device Quality Assurance, with a proven track record...RegulatoryMedical device
- ...recruiting agency is looking for a Design Quality Engineer specializing in medical devices in San Diego, CA. This role involves ensuring software quality across device functionality and regulatory compliance with standards such as IEC 62304 and FDA. The candidate must...RegulatoryMedical device
$123k - $243.4k
...Design Assurance Engineer. In this role, you will support the Design Assurance process for new medical devices, creating risk management files and ensuring compliance with regulatory standards. The ideal candidate will have a Bachelor's or Master's degree in engineering and...RegulatoryMedical deviceFull time$95k - $105k
ACON Laboratories in San Diego is seeking a Regulatory Affairs Specialist III to oversee the preparation of regulatory submissions for medical devices. The ideal candidate will have significant experience in IVD and be familiar with FDA and CE regulations. The role involves...RegulatoryMedical device$169.8k - $280.3k
...possible BD is one of the largest global medical technology companies in the world.... ...platforms (including Class I/II medical devices and non-medical devices) QMS integration... ...Minimum 10 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD,...RegulatoryMedical deviceWork at officeRemote work
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