Quality Systems Specialist - ISO 13485 & CAPA Lead
Solutech
Solutech is seeking a Quality Systems Specialist to ensure successful implementation of ISO 13485 compliant QMS policies and procedures. This role ensures processes meet quality standards and customers' requirements for medical devices. Responsibilities include maintaining calibration, document control, CAPA actions, audits, and training, while collaborating with procurement and regulatory teams. 1st shift, on-site in Washington state, with opportunity to impact patient care. #J-18808-Ljbffr Solutech
- ...Type: Job Description Position Title: Quality Systems Specialist Reports To: Director of Quality & Regulatory... ...the successful implementation of ISO 13485 certified quality management system... ...corrective action in accordance with the CAPA process (internal findings, external...SuggestedDay shift
- Senior CAPA FDA Lead Location: Bothell, Washington Visa: Any Visa Position type: C2C Contract... ...CAPA effectiveness, investigation quality, risk assessments, and HHE processes during... ...discussions. Review and strengthen CAPA systems to ensure regulatory compliance, effectiveness...SuggestedContract work
- Accord Technologies Inc is seeking a Senior CAPA FDA Lead in Bothell, Washington. The ideal... ...will have over 10 years of experience in Quality, Compliance, or Regulatory roles within... ...hands-on experience with CAPA management systems and regulatory compliance, ensuring effective...Suggested
- ...human life on Mars.SUPPLIER QUALITY SPECIALIST (STARLINK)Starlink demands a... ...deep understanding of SpaceX systems and processes.To be... ...corrective and preventive action (CAPA)Analyze supplier quality data... ...quality fieldExperience in leading improvement projects in manufacturing...SuggestedPermanent employmentTemporary workWork at officeMonday to FridayWeekend work
- We Are:Accenture is a leading global professional services... ...Plant Maintenance and Quality Management processes... ...process harmonization, system design, and go-live readiness... .../preventive actions (CAPA), Stability Studies -... ...alignment with ISO 9001, GMP, FDA 21 CFR Part...SuggestedFull timeWork experience placementLive inWork at officeLocal areaShift work
- ...to drive operational excellence across commercial properties and lead critical projects ensuring seamless day-to-day building... ...operations, managing vendor relationships, and ensuring all building systems exceed client expectations. Ideal for someone with 3-5 years experience...
$102.78k - $131.78k
Immunomeinc in Bothell, Washington is seeking a Senior IT Systems and Support Technician. This onsite role focuses on advanced technical support, IT service management, and cybersecurity within a biotech environment. The ideal candidate will possess extensive experience...- ...seeking a highly experienced professional to lead FDA audit and inspection readiness... ...This role requires 10 years of expertise in Quality, Compliance, or related fields within regulated... .... The ideal candidate will own CAPA effectiveness, prepare for FDA inspections...
$131.3k - $237.35k
Leidos is seeking a Sytems Lead to lead cutting‑edge engineering efforts within the Undersea Systems Division (USD). This role is a unique opportunity to drive... ...designs to production. Familiarity with ISO 9001:2015 and quality‑focused engineering processes. Exposure to...Contract workFor subcontractor- Jobtailor seeks an experienced Quality Assurance professional in Redmond, WA to lead deviation investigations and ensure cGMP compliance across manufacturing operations. You will analyze CAPAs, support audits, and collaborate with cross-functional teams to drive continuous...
$36.06 - $44.71 per hour
Lead Data Center Operations & Systems Technician Redmond, WA About Blueprint Blueprint is a technology solutions firm headquartered in Bellevue, Washington... ...recovery requirements. Establish and maintain high‑quality technical procedures, network diagrams, maintenance...Hourly payFlexible hours$80k - $100k
Supplier Quality Specialist (Starlink Supply Chain Reliability) SpaceX was... ...and internal risk reviews, leading failure investigations, and... ...identify trends and pinpoint systemic root causes Partner with Supply... ...and preventive action (CAPA), and Production Issue Ticket...Permanent employmentTemporary workRemote workWeekend work$85k - $130k
SPACE EXPLORATION TECHNOLOGIES CORP in Redmond, WA is seeking a Supply Chain Quality Specialist to manage supplier quality activities. This role aims to eliminate vendor-caused defects and drive supplier improvements. Successful candidates will have a strong technical...$117.2k - $313.7k
...Ready to level-up your career at the company leading workforce transformation in the agentic... ...-scale data pipelines and observability systems that power metrics, logging, and real-... ...monitoring and alerting, and ensuring data quality and system visibility at scale. Ideal candidates...Full time- Bristol Myers Squibb’s Bothell site seeks a Technical Manager, QA Programs & Systems, to own QA Shop Floor programs and drive cross-functional quality initiatives. You will coordinate change controls, risk assessments, and lifecycle management across Manufacturing, QA,...
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...Associate Director, Supplier Quality and Audits supports the... ...Program. This role leads supplier audit... ...management, quality agreements, CAPA management, and... ...Immunome’s Quality Management System, while maintaining an... ...ASQ CQA, CMQ/OE, RQAP, ISO 9001/13485 Lead Auditor, RAC) or...Contract workAfternoon shift- BW SOFTWARE US CORP in Redmond, WA seeks a Design Manager - Systems & Communications to lead design and integration efforts for critical systems. This on-site role requires coordinating with engineering, project management and client teams to ensure alignment on scope...
- ...TECHNOLOGIES CORP is seeking a Senior Mechanical Engineer in Redmond, WA, to support the design and maintenance of HVAC and plumbing systems in our Starlink Production facility. You'll drive improvements, troubleshoot issues, and oversee projects to ensure compliance and...
- ...Quality Control Specialist Our client is seeking a dedicated Quality Control Specialist to join their team. As a Quality Control Specialist,... ...~ Knowledge of quality standards and methodologies (e.g., ISO 9001, Six Sigma, GMP) ~ Proficiency in inspection tools and...Weekly payTemporary workFlexible hours
- ...ManpowerGroup in Bothell, WA is seeking a Quality Control Specialist to join its Quality Assurance team. You will perform inspections, tests on... ...or equivalent, 0–2 years in quality control, knowledge of ISO 9001/Six Sigma/GMP, and hands-on experience with inspection...
- ...Job Summary (List Format): - Architect and deliver end-to-end AI systems and frameworks, focusing on balancing speed, reliability, and maintainability. - Design and implement complex cloud architecture for large-scale AI platforms, including compute, storage...
- .... Provide Innovative product, system and component design solutions... ...design verification testing. Lead or support design changes and... ...design reviews to meet device quality, capability, and functional requirements... ...the patents. Support CAPA, Complaints and NC investigations...
$35 - $41 per hour
A leading real estate services firm seeks a Senior Building Engineer to monitor and maintain building systems, including plumbing, electrical, and HVAC. The ideal candidate will possess 5-8 years of experience in a similar role, along with required certifications. Key responsibilities...Hourly payAfternoon shift- SpaceX is seeking a Supplier Quality Specialist for Starlink to manage supplier quality... ...and production teams. You will lead non-conformance management, SDR/MRB/CAPA processes, and build strong... ...while gaining exposure to SpaceX systems and processes. #J-18808-Ljbffr...
- Leidos is looking for a Systems Lead to oversee engineering efforts within the Undersea Systems Division in Lynnwood, Washington. You will lead a multidisciplinary team in the development of advanced maritime technologies for Navy missions, ensuring technical rigor and...
- Meta seeks an experienced Prototype Build Engineer to lead prototype builds from concept through delivery. You will partner with internal... ...vendors to plan resources and manage schedules, delivering high-quality prototypes on time. Responsibilities include collaboration with...
- Prime Electric is seeking a Security Preconstruction Lead to define, design, and price complete electronic security systems at the front end of projects. You will translate client intent and site conditions into clear system architecture, scope, and cost estimates, guiding...
- Leidos is looking for a Firmware Systems Manager in Lynnwood, WA, to lead teams developing low-level software for autonomous maritime systems. This role encompasses technical leadership for embedded software, people management, and the execution of program objectives....
- ...manufacturing, and delivering high-quality biotics for dietary... ...our Quality Assurance Specialist position to work in our... ...the Customer Service Lead. Schedule is Monday... ...production deviations, CAPAs, product complaints,... ...and execution of quality systems, and performs routine day...Full timeTemporary workWork experience placementSummer workWorldwideMonday to Friday
- SpaceX in Woodinville seeks a Quality Specialist to lead inspection and quality systems within the Precision Machining shop. You will drive efficiency, standardize processes, and implement new inspection tools while collaborating with engineers and inspectors. The role...Shift work
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