QA Investigations Lead - CAPA & Root Cause Analysis
Socket.dev
Otsuka ICU Medical in Austin, TX seeks an Investigations Specialist to review and approve nonconformances, assess impact, determine root cause, and identify CAPAs to prevent repeats. You will track events and CAPAs to ensure timely closure and maintain compliance with FDA and corporate policies. The role collaborates with Quality, Operations and Regulatory/Compliance, writes technical summaries, organizes data, and ensures timely approvals of records. #J-18808-Ljbffr Socket.dev
- ...QA Supervisor Reporting to the QA Manager, the QA Supervisor... ...Austin area, Goodkind is a leading manufacturer of clean and green... ...-up of deviations, NCRs, CAPA, and change control records Support investigations and root cause analysis activities in collaboration with...Suggested
- ...and enhance the customer journey. Position Summary The QA Lead is responsible for establishing and leading quality... ...criteria and quality gates prior to production release.• Lead root-cause analysis on data quality incidents and drive corrective and preventive...SuggestedWeekly payFull timeWork at officeLocal area3 days per week
$145k - $165k
...leadership to build scalable quality systems, lead cross-functional teams, and influence... ..., and inspection operationsLead root cause investigations, CAPA initiatives, and risk management... ...initiativesStrong knowledge of statistical analysis, quality tools, and structured...Suggested$95k - $145k
...system validation strategy, audit readiness, CAPA management, and risk-based compliance... ...team, you will be responsible for… Lead end-to-end validation activities for GxP... ...activities for validation findings, including root cause analysis, effectiveness checks, closure...SuggestedRemote workVisa sponsorship- ...global footprint, and industry-leading material quality (99.8% pure... ...conformance processes, including root cause analysis and corrective/preventive actions (CAPA) Oversee supplier quality... ...Manage customer complaints, lead investigations, and implement corrective...SuggestedFull timeCasual workWork at office
- ...Supplier Quality Manager to lead supplier quality,... ...& Corrective Action Lead investigations and resolution of supplier-related... ...escapes. Drive structured root cause analysis and corrective action using... ...as 8D, 5 Why, Fishbone, and CAPA . Manage Supplier Corrective...Contract workLocal area
$180k - $225k
...artery disease, the #1 cause of death worldwide... ...Heartflow FFRCT Analysis—provides a color-... ..., documentation, investigation, and closure... ...Product Investigations Lead the Product Investigations... ...of PI, ensuring root cause analysis is... ...issues into CAPA, risk management file...Work experience placementLocal areaWorldwideRelocation- ...talented Team. Job Title: QA/Test Manager 2. Location:... ...testing activities as well as analysis and testing tasks related to software... ..., business users, and Vendor.Lead triage efforts and the... ...Review defects for themes, conduct root cause analysis, and suggest improvements...For contractors
- ...passionate about developing leading-edge electronics for satellites... ...requirements, drives root cause and corrective action activity... ...needed.Oversee nonconformance investigations and root cause corrective action... ....Proficiency in root cause analysis and structured problem-...Permanent employmentFull timeContract workWork experience placementWork at officeLocal area
- ...QA Test Manager Location: Austin, Texas (ONSITE) Contract: 12 months+ potential... ...an experienced QA Test Manager to lead quality assurance and testing efforts for... ...defect triage, prioritization, tracking, and root cause analysis Provide regular status updates on...Contract work
- ...performance. You will lead the lab department to implement... ...Lead or support investigations (deviations, OOS/OOT, contamination... ...solving and risk analysis tools such as 8D, RCA,... ...engineering, or QA role Working knowledge... ...design of experiments, cause and effect diagrams, 8D...H1bWork at officeFlexible hours
- ...seeking a Director of Test Engineering to lead a global team developing test solutions... ...and customer returns, with disciplined root cause and corrective actionSupport capital planning... ...characterization, qualification, yield analysis, and production test...WorldwideShift work
- ...experienced Quality Manager (NDT Level III) to lead the development and implementation of a... ..., corrective and preventive action (CAPA), and audit processes.Ensure compliance... ...reviews and process validations.Drive root cause analysis and corrective actions for non-conformancesNDT...Permanent employmentTemporary work
- ...environments. Collaborate with cross-functional teams (architecture, firmware, drivers, platform, and workload teams) to drive root-cause analysis through to resolution and performance closure. Proactively drive continuous improvement of post-silicon performance...
- ...integration verification, and product reliability analysis and validation. Detailed Description... ..., cost effectiveness and resilience. Lead the development and implementation of... ...& reporting. Troubleshooting & Root-Cause: Oversee troubleshooting, debugging and...Work at officeLocal areaWorldwideShift work
$80k - $100k
...corrective action closure Administer the CAPA process and analyze audit/quality... ...improvement principles Experience with root cause analysis, CAPA processes, and performance measurement... ...Willingness to travel Onterris is a leading global environmental solutions company...Work at office- Company Description LTD Material, LLC is a leading provider of high-quality products for... .... Lead customer complaint investigations and corrective action processes , including... ...Statistical Process Control (SPC), root cause analysis, and continuous improvement methodologies...Worldwide
- .... You will review batch records, assess data for quality risks, and support investigations, CAPA, and change control to improve reliability and compliance. Ideal candidates have 3+ years in QA within regulated manufacturing, strong GMP knowledge, and experience with batch...
- ...diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that... ..., instrumentation, data acquisition, certification testing, root-cause analysis, and development lifecycle gates.Experience standing up lab...Full timeVisa sponsorshipFlexible hours
- ...tools in accordance with current QA Program standards and client... ...assignment, containment, root-cause evaluation, corrective action,... ...authorities having jurisdiction; lead quality coordination, inspection... ...audits, structured root-cause analysis, and coordination of special...Full timeContract workTemporary workFor contractorsWork at officeShift work
$39.52k - $45.76k
...improvement. Coordinates investigations and ensures compliance with deadlines... ...). Supervises entry level QA position, if applicable.... ...statistical compilation and analysis, and database access.... ...are met . Sevita is a leading provider of home and community...Local areaFlexible hours$158.5k - $218k
...while learning every day in a supportive leading global company. Visit our Careers... ...Problem Solving (APS), and statistical analysis tools)Work closely with all organizations... ...the right owner is identified to execute root cause and establish corrective actions.Coordinate...Full time- ...professional services company with leading capabilities in digital,... ..., nonconformance, deviation, CAPA, change control, and... ...management, certificates of analysis, and batch-related quality workflows... ...charge, (b) in furtherance of an investigation, proceeding, hearing, or...Full timeWork experience placementLive inWork at officeLocal areaFlexible hours
- A leading IT services provider in Austin, Texas is looking for a professional to manage customer relationships and develop business requirements. Responsibilities include analyzing processes, documenting test cases, and overseeing project documentation. Ideal candidates...
$121.3k - $218.3k
...organization needs. Jabil is a leading product solutions provider... ...This is not a traditional QA manager nor manual test role.... ...performance reports, data, and analysis. Develop, determine, and... ...contact the Federal Bureau of Investigations internet crime hotline ( the...Full timeTemporary workWork at officeLocal areaRemote workWorldwide- ...Experience in standing up a QMS is preferred ~ Proficient in quality tools such as root cause analysis, Failure Modes and Effects Analysis, and Statistical Process Control ~ Proven ability to lead cross-functional teams and manage projects ~ Excellent analytical and...For contractors
- ...Primary)Job DescriptionSanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the... ...customer satisfaction levels.Support plants as necessary with root cause analysis, 8D, problem solving while driving consistent and lasting improvementsEnsure...Permanent employment
- ...leader who doesn't just rely on legacy QA methodologies, but actively leverages cutting... .... Team Leadership & Upskilling: Lead and mentor the QA and delivery teams.... ...integrated with Jira. Ensure efficient triaging, root-cause analysis, and cross-functional communication...Full timeWork at officeLocal area
- ...candidate to join our talented Team.Job Title: QA/Test Manager 3Location(s): Austin, TX... ...experienced QA/Test Manager 3 professionals to lead quality assurance efforts for a large-... ..., reconciliation reports, and exception analysis.Perform pre-load and post-load validation,...
- ...DescriptionQA Automation leadBachelor’s degree in Computer Science, Information Technology, or a similar field.Proven experience as a QA Test Lead or similar role in a professional software development setting.In-depth understanding and hands-on experience with Java and...For contractors
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