- Stryker (Irvine, CA)
- …engineering or related discipline. + 4+ years' related experience required. + Medical device industry experience required. + Familiarity with New Product ... quality documentation to support new product development and regulatory submissions. + Maintain and improve quality ...or Black belts are preferred. + Experience with the medical device development lifecycle, including risk management… more
- Abbott (Alameda, CA)
- …File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Collects, organizes, ... serve people in more than 160 countries. **Job Title** ** Quality Engineer II** **Working at Abbott** At Abbott, you...of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer… more
- Cordis (Irvine, CA)
- …date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these ... Engineering, Biomedical Engineering, or a related Engineering field. + 5+ years in medical device production development + Previous experience working in a… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …field (advanced degree preferred). * Minimum 15 years of progressive experience in Design Quality Assurance within the medical device industry. * At least ... **Job Description Summary** The Director, Quality Engineering - WW IPD is responsible for...and technical QA staff. * Deep knowledge of global medical device regulations (FDA, EU MDR, etc.).… more
- Abbott (Pleasanton, CA)
- …Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in medical device manufacturing or other ... peers understand quality system requirements and how they impact product quality and regulatory compliance. + Represents the division within Abbott through… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …knowledge of medical terms and human anatomy + Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations + Good ... and other departments/business units for complaint investigations + Evaluate complaints for Medical Device Reporting (MDR) + Prepare and submit MDR reports… more
- Abbott (Sylmar, CA)
- …and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of software ... Quality , Compliance, Engineering, within a regulated environment, such as medical device , diagnostics or pharmaceutical industries, to develop the competence… more
- Cordis (Santa Clara, CA)
- …combination of education and experience preferred + Expertise in the FDA and International Medical Device Quality System Regulations and ISO 13485 + Six ... + Ability to comprehend principles of engineering, chemistry, polymers, physiology, and medical device use. **REQUIRED KNOWLEDGE, SKILLS, ABILITIES** + Excellent… more
- Stryker (Irvine, CA)
- …**Preferred:** + MS, CQE, or CRE. + Six Sigma Green or Black belt. + Medical device industry experience is strongly preferred. + Experience in interacting with ... Stryker - Inari Medical (https://www.inarimedical.com/) is hiring a **Staff Quality...MoH, TUV, etc.). + Understanding of US and International Medical Device Regulations. + Familiarity with ISO… more