- AbbVie (Irvine, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager , Medical Device Quality Systems is responsible ... both current and emerging regulations and standards impacting AbbVie medical device and combination products. + Performs...professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality… more
- AbbVie (Irvine, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to… more
- Edwards Lifesciences (Irvine, CA)
- …related to event interpretation, event investigation, proper coding, required regulatory reporting ( Medical Device Reports, Medical Device Vigilance, ... patients around the world with pioneering technology. As a Manager , Product Quality Clinician you will be...with reporting decisions. + Reviews complaint codes and FDA Medical Device Reports, reviews and assists with… more
- Integra LifeSciences (Irvine, CA)
- …Science. + Minimum of eight (8) years' experience in a regulated environment, preferably Medical Device . + Working knowledge of appropriate global medical ... the strategic leadership, management and direction of the Irvine Quality functions by developing a best-in-class quality ... standards such as ISO 13485, and European Union Medical Device Law such as MDD/MDR. +… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …and technical knowledge + Five years of people management experience + Experience in medical device industry + Experience working in a design center For certain ... **Job Description Summary** Reporting to the Associate Director, Unit Quality WW IPD, the Senior Manager -...product development and product maintenance through the application of Quality engineering skills for medical devices, assuring… more
- ICU Medical (San Clemente, CA)
- …the support of an established Core Team and Program Managers, through the medical device product life cycle of development, qualification, manufacturing, and ... in product development leading multi-site global programs . Experience in the medical device or other regulated industry with equivalent design controls… more
- ICU Medical (San Clemente, CA)
- …for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards ... assurance support for product realization/manufacturing teams. Reporting to the Quality Manager , this individual will be the...the FDA and other regulatory agencies with respect to medical device compliance. . Provides compliance guidance… more
- Burns & McDonnell (Brea, CA)
- …biotechnology, animal health and medical device industries. The Project Manager will be responsible for project safety, quality , schedule, cost control, ... **Description** The Life Sciences & Technology Project Manager will lead and motivate a team in...of pharmaceutical, biotechnology, animal health, cell & gene therapyor medical device .is preferred. + Excellent written and… more
- Envista Holdings Corporation (Yorba Linda, CA)
- …+ Knowledge of automation equipment and principles. + Working knowledge of medical device regulations. + **Critical Skills/Technical Know-How:** + Excel in ... years of experience in machining processes is a plus. + Experience in a regulated medical device environment and clean room experience is a plus. **Target Market… more
- J&J Family of Companies (Irvine, CA)
- …or related industry setting technical experience + 3+ years of medical device experience, especially in cardiovascular and/or electrophysiology therapeutic ... Biosense Webster Inc. is recruiting a Manager , Clinical Science & External Research (Scientific Communications)...Experience training internal and personnel on clinical evidence supporting medical device products + ISMPP CMPP (TM)… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …any other related field. 2. Minimum eight (8) years of relevant work experience in medical device industry. 3. Minimum two (2) years of management experience. 4. ... **12368BR** **Title:** Sr. Manager , Engineering R&D **Job Description:** Manage individuals from...Minimum twelve (12) years of relevant work experience in medical device industry. 3. Minimum three (3)… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …any other related field. 2. Minimum six (6) years of relevant work experience in medical device industry. 3. Minimum one (1) year of management experience. 4. ... **12440BR** **Title:** Engineering Manager , R&D **Job Description:** Manage individuals from entry-level...Minimum ten (10) years of relevant work experience in medical device industry. 3. Minimum two (2)… more
- Cordis (Irvine, CA)
- …Stay up-to-date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to ... MDR, with potential for this position to assume the quality program manager on MDR. + Supplier...a related field. + At least 8 years in medical device production development + Previous experience… more
- Fotona (Irvine, CA)
- …medical laser market. Gynecology Sales experience as well as Capital Equipment, Durable Medical Equipment, and/or Medical Device experience, and a proven ... excellence is earned from its dedication to R&D, unparalleled quality , reliability, ease of use, and durability. Fotona is...and/or Women's Health strongly preferred. + Capital Equipment, Durable Medical Equipment, and/or Medical Device … more
- Cordis (Irvine, CA)
- …the appropriate channels **Qualifications** + A minimum of 5 years of experience in the medical device space, with a managerial or leadership role for at least 3 ... the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …Word, Excel, Outlook, and Teams. **Desired Qualifications** 1. Master's degree. 2. Medical device or life sciences organization experience or equivalent ... **12407BR** **Title:** Sr Manager , Field Inventory **Job Description:** Provide thought, vision,...building and maintaining strong partnerships with Finance, Sales, Marketing, Quality Assurance, Marketing, Supply Chain, and Customer Service. Job… more
- Envista Holdings Corporation (Yorba Linda, CA)
- …+ 2+ years of experience in the field of contamination control in the medical device or pharmaceutical industry + Must reside within a commutable distance ... **Job Description:** The Cleanliness and Contamination Control Manager is responsible for ensuring cleanliness control and...Yorba Linda, CA. **Critical Skills/technical know-how:** + ISO 13485 ( Quality Management System for Medical Devices) +… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …MS Word, Excel, Outlook, and Teams. **Desired Qualifications** 1. Previous medical device industry experience. 2. SAP experience. **External-Facing Title:** ... **12339BR** **Title:** Manager - Sales Operations, Contracts & Pricing **Job...and changes to pricing for existing products. + Support Quality Assurance activities relating to field corrective actions. +… more
- Integra LifeSciences (Irvine, CA)
- …in English (Verbal and writing). + Prior management experience in foreign multinational medical device company highly preferred + Strong written and verbal ... possible and making headway to help improve outcomes. **SUMMARY:** The Plant Manager is responsible for all operations at Integra's Irvine, California site. In… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …experience in a relevant law firm, consulting firm or corporate setting. Medical device , pharmaceutical, or other healthcare-related experience in a compliance ... **12377BR** **Title:** Manager , Global 3rd Party Mgmt & LATAM Mgmt...with and advise the commercial organization and the Global Medical Affairs function to ensure the HCP interaction and… more