Quality Engineer I: CAPA, NCRs & Process Validation
RedBrick Staffing
RedBrick Staffing is seeking a technically minded QA/Regulated Documentation Assistant in Irvine, CA to support quality systems and manufacturing documentation in a fast-paced medical device environment. You will draft and route quality records, assist CAPA investigations, and maintain controlled documents within the eQMS, ensuring compliance with ISO 13485 and FDA regulations. This role offers growth opportunities and on-site collaboration with cross-functional teams in a regulated setting. #J-18808-Ljbffr RedBrick Staffing
$99k - $120k
...re looking for a Sr. QA Engineer to help build quality into every stage of our medical... ..., risk management, CAPA, validation, and our Quality Management... ...support new products and processes, and help ensure what we... ...investigations of NCRs, complaints, and deviations...SuggestedRemote work- Quality EngineerPosition OverviewWe are seeking... ...detail-oriented Quality Engineer to ensure product and process quality through... ...preventive actions (CAPA) using methods such... ...APQP and verification/validation plans.Monitor, report... ...(DPPM, yield, OEE, NCRs) and present findings...Suggested
- Draft & route NCRs - from cradle to grave Support CAPA investigations Support doc control... ...internal audits Support CMO process development: document... ...items Support process validation (IQ/OQ/PQ): protocol execution... ...: Bachelor's degree in Engineering or similar 1+ years of...Suggested
- ...depending on exerienceYour role as a Quality Engineer in the manufacturing sector of... ...of the manufacturing processes for a variety of vascular devices... ...in risk management, process validation, quality tools, lean manufacturing principles, CAPA, statistical analysis, and documentation...Suggested
$89.4k - $148.9k
...OnsiteStryker is hiring a Senior Quality Engineer for our Peripheral Vascular... ...operations, products, and processes. Partner closely with cross-... ...nonconformances (NCs), CAPAs, MRB activities, and product... ...process, equipment, and supplier validations/qualifications, measurement...SuggestedFull timeFor contractorsWork at office- ...Rate High: 44.00 Exciting Quality Engineer II development opportunity... ...risk management, verification/validation, change control, and product... .... Assess product and process changes for quality and regulatory... ..., root cause analysis, and CAPA activities. Ensure...Permanent employmentContract workH1b
- ...are seeking a Supplier Quality Engineer to work on a team at... ...and devices. Ensures validation methods of critical suppliers... .... Knowledge of NCR & CAPA elements is preferred.... ...Cause Analysis, dFMEA process, Gage R&R, etc.)... ...effectiveness as applied to NCRs and SCARs Experience...Hourly payLocal area
- ...Quality Engineer IIIImagine working with a global innovator in advanced electronic... ...methods, and robust product validation activities. • Analyze quality data... ...corrective and preventive actions (CAPA) to maximize product reliability and process efficiency. • Partner directly...
$80k - $95k
...solutions, delivering superior quality and support to Original... ...the world. QUALITY ENGINEER Job Purpose:... ...data-driven process improvements. The ideal... ...diagnose process drift, and validate part conformance to customer... ...for corrective actions (CAPA). Continuous...Permanent employmentWork experience placement$100k - $120k
...Until Filled Job Title: Quality Engineer III Location: Irvine, CA;... ...champion product excellence, process optimization, and ultimate customer... ...methods, and robust product validation activities. • Analyze... ...and preventive actions (CAPA) to maximize product reliability...Full timeLocal areaShift workDay shift- ...immediate opening for a Supplier Quality Engineer responsible for managing... ..., and other operational processes, as well as ensuring that quality... ...in supplier production validations. Maintain supplier quality records... ...Proficiency leading CAPA investigations and supplier...Local areaImmediate start
- ...POSITION Quality Engineer Test Method Validation (TMV) Start date & Location Hybrid Irvine, CA (locals ONLY) REQUIRED SKILLS Key Responsibilities Lead and execute TMV remediation activities. Develop, review, execute, and...Local area
- ...Description: We are seeking a highly experienced Principal Quality Engineer to lead quality engineering initiatives in a regulated... ..., product quality improvements, risk management, CAPA activities, process validation, and compliance programs. The Principal Quality...Remote work
- ...collaborative Senior Quality Engineer to join our team in a... ...product quality, drive process improvements, and uphold... ...-conformance reports (NCRs), root cause analysis,... .../preventive actions (CAPA). Conduct internal audits... ..., and verification/validation activities. Effective...
- ...and staffing solutions across Quality & Validation, Regulatory Affairs, R&D,... ...Position: Senior Supplier Quality Engineer Plastics Location:... ..., mold qualification, process validation, and supplier quality... ...supplier corrective actions, SCAR, CAPA, and 8D activities....
- Title: Quality Assurance Engineer Duration: 12 months (Contract) Location: Costa Mesa, CA(100%... .... Responsibilities Product and Process Quality Audits Perform in-process... ...plans, and work instructions to validate product requirements. Inspect consolidated...Contract workWork at officeDay shiftAfternoon shift
$120k
Turion Space is seeking a Senior Quality Assurance Engineer to join our growing team in Irvine, CA. You... ...Assurance, you'll help build out inspection processes, calibration systems, and QMS... ...RCCAWork open Nonconformance Reports (NCRs) end-to-end: containment, root cause investigation...Permanent employmentFull timeContract workWork at officeShift workDay shift- Hyundai Autoever America is seeking a Sr. Software Quality Analyst/Test Engineer in Costa Mesa, CA. The successful candidate will develop test specifications, execute testing activities, and manage validation projects. This role supports quality assurance across various...
- ...product development activities (e.g. engineering testing, design and process characterization, and other V&V activities) Assists in conducting Quality Assurance documentation reviews and... ...of relevant process development and validation activities (e.g. IQ/OQ/TMV/APQ) Utilizes...
- ...391 Job Summary: We are seeking a Quality Engineer with experience in the Medical Device... ..., Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product... .... Support Change Control and CAPA processes. Ensure compliance with GxP requirements...
$85k - $125k
...Terran Orbital is seeking an experienced Quality Engineer to join our dynamic team. Reporting to... ...for the plant's products and development process, primarily focusing on our module and vehicle... ...flow and control plans, etc.) and CAPA and RCCA to drive product and process defect...Permanent employmentContract workWork at officeLocal areaFlexible hours- ...are seeking an experienced Lead Quality Engineer to provide technical leadership for... ...quality improvement initiatives, validation activities, risk management, CAPA, nonconformance investigations,... ...investigations. Support and lead process validation, equipment qualification...
- Anduril Industries in California is seeking a Quality Engineering Specialist to join our defense technology team. You will monitor, inspect,... ...quality standards in a fast-paced environment. You will own MRB processes, lead containment of nonconforming parts, perform root-cause...
$105k - $120k
Aliso Viejo, CA • Quality Job TypeFull-timeDescriptionRxSight... ...:The Senior Quality Engineer I position requires significant... ...post-market and quality processes. Responsibilities will include... ...and preventive actions (CAPA).Lead and support validation activities (IQ/OQ/PQ),...- ...ready to join us?This role is part of Alcon's Engineering function, a team focused on improving quality, processes, products, packaging and materials across our... ...of Corrective and Preventive Actions (CAPAs), validations, and verifications, and facilitate investigations...Hourly payFull timeTemporary workRelocation packageMonday to FridayFlexible hoursDay shift
- ...Reference26-00604 Job Summary: The Sr Quality Engineer will support product development and cleanroom... ...assurance, risk management, and validation activities in collaboration with cross... ...cleanroom build support Ensure NPD processes comply with the quality system and applicable...
- ...Software Quality Engineer Relevant Experience(in Yrs) - B.S. in Electrical or Computer Engineering or B.S. in Biological... ...working knowledge of software lifecycle development process, product and process validation activities. Technical/Functional Skills - Ability...
$60 - $85 per hour
...Job Title: Software Test Engineer Job Description The Software... ...a key role in verifying and validating safety-critical flight software... ...automating existing testing processes, developing code coverage... ...to ensure reliable and high-quality software in a demanding aerospace...Contract workTemporary work- ...improvement, and delivering high-quality products that meet the evolving needs... ...seeking an experienced Quality Engineer III to help drive product quality, process excellence, and customer... ...inspection methods, and product validation activities. Analyze quality data...
$80 per hour
...Quality EngineerMax. salary: 95KMedical Devices Industry... ...and life cycle processes between customer team... ...Technical Training in Quality Engineering principles, Risk... ...close design control CAPAs. Assess design control... ...engineer during process validation execution and protocol...
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