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$135k - $165k
...collaborate directly with senior engineering leadership. \n Support quality and process improvements as the company works toward ISO 13485 certification. \n \n \n Required Qualifications \n \n ~ Bachelor's degree in Electrical Engineering, Computer Engineering...SuggestedTalent Harbor
Bothell, WA3 days ago- ...Education / Experience (PREFERRED) : \n \n Two-year technical degree is a plus . \n Experience in medical device or GMP/ISO environments. \n Experience operating a CMM (Coordinate Measuring Machine). \n Strong project management skills. \n Ability...SuggestedFull timeWork experience placementWork at office
Consulting Direct
Bothell, WA20 days ago $130k - $140k
...and manufacture our technology fully in-house , operate in a high-trust / high-regulation environment , and we’re on the journey from ISO 9001 toward ISO 13485 readiness . This is your opportunity to lead, influence, and build. Why You’ll Love This Role ✔️ You will own...SuggestedFull time$30.61 - $37.09 per hour
...be able to stand/walk for extended periods of time Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety...SuggestedHourly payFull timeSummer workLive inLocal areaImmediate startRemote workFlexible hoursShift workNight shiftWeekend workAfternoon shift- ...Demonstrate attention to detail and strong record keeping skills, preferably in a regulated manufacturing environment (FDA cGMP/QSR or ISO experience is a plus). Possess good manual dexterity, eyesight, and ability to use a microscope for assembly tasks. Are...SuggestedHourly payTemporary workLocal areaAfternoon shift
Kelly Services
Bothell, WA12 days ago $32 - $49 per hour
...nonconforming material. Identify, tag, segregate, and quarantine the material, and keep lot and serial traceability correct at each move (ISO 9001, AS9100). Do the containment actions. Sweep stock, work-in-process, in-transit, and finished goods to find all affected...SuggestedHourly payPermanent employmentContract workWork at officeLocal area$25.2 per hour
...within a manufacturing production environment (required) Are experienced working in a quality control environment (FDA cGMP/QSR or ISO preferred) Are a strong team player, willing to take on a variety of tasks in a dynamic environment Are proficient with software‑based...SuggestedHourly payShift workWeekend workWeekday work$70k - $85k
...are unable to meet this requirement, we kindly ask that you do not apply. The Opportunity As a modern technology consulting firm, ISO is at the forefront of change. We strengthen our clients with technological solutions that help them boost performance, streamline processes...SuggestedLocal areaRemote workRelocationNight shift$155.55k - $221.12k
...Skilled at developing applications on a variety of levels including bare metal systems, RTOS and embedded Linux * Working knowledge of ISO 13485, ISO 14971 and IEC 62304 standards and applying this to medical device development * Proven mastery of software engineering...SuggestedFull timeTemporary work$111.49k - $150.84k
...experience in manufacturing Excellent analytical, technical writing and verbal communication skills Knowledge of FDA (820.50 & 60) and ISO (13485) requirements Certified Quality Auditor (CQA, RAB) certificate or Certified Quality Engineer (CQE) certificate preferred...SuggestedFull timeWork experience placement$143k - $291k
...aspects of Sales Agreement terms and conditions. Ensures strict adherence to defined sales process and policies including FDA/GMP and ISO regulations. Develop an annual business plan with specific target account goals/forecasts for each territory within the region while...SuggestedLocal areaFlexible hoursNight shift- ...components against mechanical, electrical, and PCBA specifications. You will own MRB containment, write NCRs, allocate daily inspection work, and guide less-experienced inspectors while upholding ISO 9001/AS9100 standards under production pressure. #J-18808-Ljbffr IonQ, Inc.Suggested
$90.9k - $150k
...work experience accepted inlieu of a formal degree. ~7 or more years of related experience in a regulated environment. Experience in ISO, GMP or FDA regulated environments preferred. ~ Working experience in the biotech/life science industry is preferred. ~...SuggestedFull timeTemporary workWork experience placement$175.1k - $240k
...occasional evening/weekend commitment to support audits and inspections. Professional certifications (e.g., ASQ CQA, CMQ/OE, RQAP, ISO 9001/13485 Lead Auditor, RAC) or equivalent quality/auditing/regulatory certifications are highly desirable. Knowledge and Skills Strong...SuggestedContract workAfternoon shift- ...recalls, or advisories. Support regulatory reporting decisions (FDA, EU MDR). Risk Management Conduct and update risk assessments per ISO 14971. Maintain and update: Risk Management Files (RMF). Hazard Analysis, FMEA, Fault Tree Analysis. Ensure risk controls are...Suggested
$105k - $145k
...Fields of Study: Chemistry, Biology, Engineering, Pharmacy, or related scientific/technical field • Lead Auditor certification in ISO 9001 preferred • 3-5 years of leadership/management experience • Comprehensive knowledge of quality management systems and regulations...Remote jobFull timeTemporary workWork at office$25.2 per hour
...within a manufacturing production environment (required) Are experienced working in a quality control environment (FDA cGMP/QSR or ISO preferred) Are a strong team player, willing to take on a variety of tasks in a dynamic environment Are proficient with software...Temporary workLocal areaWeekend workWeekday work$105k - $145k
...pharmaceutical, medical device, or regulated industry ~3-5 years of leadership and management experience ~ Comprehensive knowledge of ISO 9001, ISO 13485, FDA QSR/cGMP regulations ~ Expertise with quality tools including CAPA, risk analysis, FMEA, and root cause...- ...actions. The role balances technical inspection with guidance to frontline staff. As a senior resource, you will allocate work, uphold ISO/AS standards, and drive quality under production pressure. The position is base+bonus+equity with comprehensive benefits. #J-18808-...
- ...and verifications on production and R&D materials. Requirements include a high school diploma or GED and 2+ years in a technical GMP/ISO environment, GD&T knowledge, and proficiency with measurement tools. CMM experience is a plus. #J-18808-Ljbffr Career Management GroupFull time
- ...Model injection and poisoning protection Supply-chain AI risk management Map AI platforms to regulatory requirements including: HIPAA, ISO 27001, NIST, SOC 2 EU AI Act readiness Data privacy and sovereignty standards Develop solutions for SOC automation using GenAI...Flexible hours
- ..., audits, and continual improvement of the supplier base to ensure GMP compliance and product quality. The position requires strong analytical writing and communication skills, experience in manufacturing, and knowledge of FDA/ISO requirements. #J-18808-Ljbffr Verathon
- ...compliance by evaluating field issues, complaints, and non-conformances. You will perform HHE assessments, lead risk evaluations per ISO 14971, and collaborate with R&D, QA, and field teams to drive effective risk controls and CAPA actions. #J-18808-Ljbffr Katalyst CRO
$149k - $237k
...dentistry space highly preferred. Your skills include a strong of relevant standards and regulations for the medical device industry (ISO, IEC, etc.). You have strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit...Work at officeImmediate startWork visaRelocation package$137k - $236k
...regulatory guidance, standards including (not limited to) software (IEC 62304/82304) / device lifecycle management, risk management (ISO 14971), cybersecurity, human factors (IEC 62366), clinical and bench top testing. You’re able to efficiently review typical device development...Work visa- ...seeking a QA Manager to lead the Quality function and shape strategies for compliance and efficiency. You'll collaborate with teams, drive ISO 13485 readiness, and influence a high-trust culture. Ideal candidates have over 5 years in Quality Management, experience with audits...
- ...our services to meet the specific needs of our civilian, defense, and private-industry sponsor. Our corporate support processes are ISO 9001 certified, giving our customers the confidence that we are continually measuring and improving upon the support we provide and are...Full timeTemporary workFor contractorsMonday to Friday
- Fluke Corporation seeks a Quality Systems Administrator to coordinate the Global ISO 9001 quality management processes, audits, and document control. You will support internal audits, nonconformances, corrective actions, and PLM workflow administration across multiple departments...
- ...or remote project Instrumentation support to Construction and Start Up personnel. Maintain project files of previous revisions per ISO 9001 policies. Check work of other members of the design team when needed. Will require some technical and/or procedural help....Hourly payFull timeTemporary workWork at officeRemote workFlexible hours
$140k - $180k
...reviews for new AI tools. You'll be the person IT and Security lean on when AI-specific security questions arise, operating within our ISO 27001 and SOC 2 environment. ~ Enablement & Uplift: Work directly with employees and teams through one-on-ones, small group...Casual workWork at officeWork from homeVisa sponsorshipFlexible hours
