- GKN Aerospace (Garden Grove, CA)
- …timely and accurate quality checks + Maintain compliance with AS9100, ISO 9001, and customer-specific requirements + Review inspection documentation for accuracy ... and traceability + Develop and maintain inspection plans and procedures, including FAIs and in-process inspections + Collaborate with engineering and production teams to resolve quality issues and implement corrective actions + Train, mentor, and evaluate… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …processes in accordance with cGMP. + Knowledge of FDA and EU regulations, ISO requirements. + Skill in the use of computer systems for data compilation, ... managements, and analysis. + Experience with project management (problem solving and resolution) and general business principles. + Excellent written and interpersonal communication skills as well as strategic and conceptual thinking. + Experience with leading… more
- Astrix Technology (San Diego, CA)
- …+ Strong working knowledge of GMP regulations and guidelines (eg, BPF, ICH-Q7, ISO 13485, US/EU Pharmacopeia) + Proven project management skills and ability to meet ... ambitious milestones + Detail-oriented with a strong sense of urgency and accountability + Team player with excellent communication skills and a passion for quality-driven science.INDBH We are an equal opportunity employer and all qualified applicants will… more
- Fujifilm (Sacramento, CA)
- …and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and ... standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. Key Performance Indicators: + Revenue and sales bookings targets met or exceeded for product… more
- Fujifilm (Sacramento, CA)
- …and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and ... standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** Professional Experience: + 5-10 years of progressive experience in medical… more
- Astrix Technology (Gardena, CA)
- …Minimum 2 years of experience in a regulated manufacturing environment (FDA, DEA, ISO ). + Familiarity with cGMP processes and sampling plan tools preferred. + ... Proficiency in using PPE and Microsoft/ERP systems. INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected… more
- Pearson Electronics (Palo Alto, CA)
- …to meet and train to those expectations in a manufacturing environment. Familiar with ISO 9001: 2015 a plus Familiarize with the company's product lines and its ... production requirements Start and schedule jobs to meet customer deadlines Ensure adequate material and supplies are in stock to support production Work with the Purchasing manager to ensure POs are placed for materials and supplies for production Knowledge of… more
- The Walt Disney Company (Glendale, CA)
- …practice in functional safety standards, including IEC 61508, IEC 62061, ISO 13849. + Familiarity with amusement and automation industry standards, including ... ASTM F2291 + Solid skills in technical document writing. + Ability to travel domestically and internationally for 1-week to 3-year durations. + Ability to handle multiple complex efforts simultaneously, coordinate team efforts, and manage tasks and priorities.… more
- Terumo Neuro (Aliso Viejo, CA)
- …820 - Device Labeling, 21 CFR 830 - Unique Device Identification, FDA 89-4203, ISO 15223, CDRH Guidance Document, etc.). 6. Advanced experience with MS Visio 7. ... Ability to Create, Update and Maintain MS Project GANTT's 8. Excellent written and verbal communication skills. 9. Proficient with MS Office applications, including Word, Excel, Outlook, and Teams. **Desired Qualifications** 1. Strong knowledge of global… more
- US Pacific Fleet (San Diego, CA)
- …or removal. + You will be required to obtain and maintain a current ISO 9000:2008 Internal Auditor certification. + You will be required to wear personal protective ... equipment such as helmets, gloves, coveralls, glasses, goggles, respirators and safety shoes. + This position may require travel from normal duty station to CONUS and OCONUS and may include remote or isolated sites. You must be able to travel on military and… more