Hybrid Quality Engineer — CAPA, FDA/ISO, Process Improvement
MillenniumSoft Inc
MillenniumSoft Inc is seeking a Quality Engineer in San Diego to oversee product quality evaluation and control, ensuring compliance with FDA and ISO standards. This role, which is hybrid preferred, involves working cross-functionally and applying statistical analyses to enhance quality assurance processes. The ideal candidate will have intermediate knowledge of quality engineering principles and act as a mentor to junior team members, applying regulatory knowledge with minimal supervision. #J-18808-Ljbffr MillenniumSoft Inc
- ...Title: Quality Engineer Location: Cleveland, OH,44130 Onsite... ...resolving the equipment and process-related production issues, activities... ...basic knowledge of FDA/ISO requirements. Applies basic... ...Support quality system improvements and maintenance through change...Process improvementDay shift
$83.5k - $133.5k
...of effective, high-quality medicines, assure... ...breakthroughs that improve lives worldwide.... ...us—from design and engineering to the manufacturing... ...for production processes. Track, trend,... ...Board (MRB), and CAPA activities to address... ...Familiarity with ISO 9001, ISO 13485, and...Process improvementHourly payWorldwideShift work- ...seeking a detail-oriented Quality Systems Engineer to support and... ...execution - documentation, CAPA support, and audit... ...and execution of the ISO 13485/FDA Part 820 QSMR/Part 4... ...and business process owner for the company... ...support and training to improve adoption, data quality...Process improvementVisa sponsorshipWork visa
- ...Design Verification Engineer Duration... ...compliant with Quality System Regulations... ...in accordance with processes. Develops risk... ...provides process improvement suggestions to eliminate... ...according to ISO and GMP guidelines... ...requirements (e.g., FDA QSR, ISO 13485,...Process improvement
$43 - $45 per hour
...Quality Engineer Location: San Diego, CA Onsite Flexibility: Onsite Contract... ..., cleaning, production process, equipment qualification, facilities... ...supervision. Propose improvement projects with supporting data... ...knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part...Process improvementContract workCasual workWork visaMonday to FridayFlexible hoursShift workWeekend workDay shift- Caterpillar is seeking a Supplier Quality professional to assess supplier quality and qualify production... ...You will also conduct supplier audits to ensure ISO and NADCAP compliance. The role emphasizes process improvement, QA plans, and effective supplier management to...Process improvement
$95k - $120k
...Leadership, the Senior Supplier Quality Engineer serves as a vital link... ...drive, and manage projects to improve delivery, quality and cost performance... ...are focused on product and process performance for all... ...of hands-on experience with ISO 9001 and AS9100 Quality Management...Process improvementHourly payDaily paidImmediate startMonday to FridayShift work$130k - $150k
...systems. Senior Quality Engineer (Operations)... ...robust manufacturing processes, support design transfer... ...drive continuous improvement across production... ...of effective CAPAs. Support Manufacturing... ...supplier audits, FDA inspections, and... ...Regulation, ISO 13485, and applicable...Process improvementFull timeContract workTemporary workInternshipFlexible hoursShift work$106.03k - $196.91k
...global leader in the design, engineering and production of... ...methods and procedures for process control, process improvement, testing and inspection to... ...supplier representatives on quality problems, ensures that effective... ...standards, such as ISO 9001. Required Qualifications...Process improvementContract workWork at office$140k - $160k
...responsible for conducting independent quality control (QC) assessments to... ...focused documentation and process reviews to verify that... ...corrective and preventive actions (CAPA), as needed. Track QC... ...Knowledge Sharing, and Operational Improvement Contribute to training...Process improvementWork at officeRemote workRelocation package- ...spent a good chunk of their career in CAPA. Position: Staff Quality Engineer, CAPA Location: San Diego, CA... ...enthusiasm in the business for CAPA process Minimum Requirements A Bachelor’s... ...potential to drive product quality improvement Ideal Characteristics The Staff Quality...Contract work
- MillenniumSoft Inc is looking for a Sr. Quality Engineer based in San Diego, CA. This role requires expertise in risk management and quality... ...industry standards. A strong understanding of Design Control and ISO regulations is critical. Join us for a 9+ month contract with...Contract work
- ...experienced Software Verification Engineer to support the... ...automated testing, software quality assurance, and formal verification processes within a collaborative... ..., develop, execute, and improve manual and automated... .... Experience working in FDA-regulated medical device...Process improvementMonday to Friday
- ...Sr. RMF Security Engineer Leidos has a new and exciting opportunity for a Sr. RMF... ...role is responsible for ensuring product quality through both manual and automated... ...Ability to identify efficiencies and process improvements between the development and testing disciplines...Process improvementImmediate startFlexible hours
- MillenniumSoft Inc seeks a Quality Engineer III in San Diego, CA to support the conversion from ISO 9001:2015 to ISO 13485:2016. The role requires a minimum of 2 years of medical device experience and expertise in risk assessment. The ideal candidate will communicate effectively...Part timeFlexible hours
- BioTalent is seeking a Senior Quality Engineer in San Diego to own and improve the QMS across the full product lifecycle... ...will coordinate documentation and processes across the organization. You will... ..., clinical, and operations, drive CAPA and change control activities, and...
$65 - $70 per hour
Pride Health is looking for a Sr. Software Test Engineer in San Diego, CA. The role supports software verification and validation for medical... ...in computer science, and know Agile practices. The position is hybrid, requiring in-office presence two weeks per month, and offers a...Hourly payContract workWork at office$73.45k - $132.78k
...exciting opportunity for a Software Test Engineer in our National Security Sector's (NSS... ...Engineer will be responsible for the quality of the developed product and... ...Ability to identify efficiencies and process improvements between the development and testing disciplines...Process improvementImmediate startFlexible hours- ...maintaining operational processes, including... ...with the company’s Quality Management System (... ...1 CFR Part 820 and ISO 13485. This role ensures... .... Participate in CAPA processes and continuous improvement activities. Identify... ...controlled environments. Hybrid or in‑office...Process improvementWork at office
- ...support and analyze government reimbursement processes, including Medicare and Medi-Cal. The... ...regulations. This position offers a hybrid work schedule, combining onsite work in... ...experience in healthcare finance and process improvement. #J-18808-Ljbffr University of...Process improvementRemote work
- ...business analysis skills to deliver high-quality solutions and optimize digital products... ...Agile teams, and facilitating process improvements. The ideal candidate has a Bachelor's degree... ...as Jira and Power BI. The position is hybrid and offers a dynamic environment with ample...Process improvement
- ...is hiring a Senior Quality Engineer for a medical... ...and continuously improve their Quality Management... ...and maintain QMS processes and documentation... ...approving changes Lead CAPA activities... ...Strong command of ISO quality systems and... ...device experience, FDA inspection support...
- ...Position: Sr. Quality Engineer Location: San Diego, CA Duration:... ...with Engineering change control processes, targeted knowledge with MDR... ...center that comply with ISO 13485:2016 and 21 CFR 820 requirements... .../ Change control process, CAPA, Deviations and Non-...Contract workH1b
- ...Quality Engineer 3 San Diego, CA, United States Hologic is a global... ...healthcare providers in improving access, efficiency and patient... ...regulated manufacturing processes. The Quality Engineer II will... ...Working knowledge of applicable FDA and ISO regulations and...
$100k - $130k
...Senior Quality Systems Engineer RASIRC is seeking a detail-oriented Senior Quality... ...System and related quality processes. This role is an individual... ...(QMS) in alignment with ISO 9001 and applicable customer... ...system requirements. CAPA & Nonconformance Support...Permanent employment- ...Position : Quality Engineer Location : San Diego, CA Duration :... ...manufacturing equipment and support in process validation or verification... ...working understanding of the ISO 13485 Quality Systems... ...Manufacturing Practices, ISO, FDA). Proven ability to develop...Contract workRelocationDay shift
$100k - $110k
...Job Description Job Description Quality Engineer Join a team where quality is more than... ...partnering with cross-functional teams to improve processes and product quality. In this role,... ...corrective and preventive actions (CAPA) that deliver long-term results. Partner...Process improvementPermanent employmentTemporary work$30 - $35 per hour
...job summary: Join Our Client as a Quality Engineer in San Diego, CA a global leader innovating... ...'s, 0-2 years of experience, and GMP/FDA/ISO knowledge to ensure top product quality... ...for changes related to raw materials, in-process components, and finished products....Hourly payContract workTemporary workWork experience placementLocal areaWorldwide$131.82k - $168.8k
...us-from design and engineering to the manufacturing... ...Assist with all quality aspects of the design control process: quality planning;... ...including 21 CFR 820, ISO 13485, ISO 14971 and... ...Preventive Action (CAPA); Engineering... ...accountable, and learn and improve every day. To...Hourly payShift work- ...Position: Quality Engineer II Location: San Diego, CA... ...must haves on resume: ISO 13485 Quality Systems... ...critical systems (ie processed water and compressed air... ...owners. 3. Experience on CAPA (Corrective Action and... ...or continuous improvement activities. 4. Experience...Contract workRelocation
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