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- ...with international shipping (preferred). Experience working within a rigorous, quality control environment such as FDA cGMP/QSR or ISO. A strong team player with demonstrated abilities and willingness to wear multiple hats, to perform a wide range of tasks (from...SuggestedWeekend workWeekday work
- ...in Manufacturing Engineering, working with quality control systems, preferably in electronics or medical device as well as in a GMP/ISO environment Computer proficient; confident using data analysis programs and Microsoft Suite Experience using CAD (computer aided design...SuggestedWork at officeLocal area
$55k - $65k
Location requirement: Candidates must be able to commute daily to our Bothell, WA office. The Opportunity At ISOutsource (ISO), we believe great technology starts with great people. We’re a modern technology consulting firm helping organizations work smarter, move faster...SuggestedWork at officeLocal areaNight shift$24.03 - $31.75 per hour
...organization Ability to work in a team environment Willingness to learn and grow Familiarity with MS Office software Familiarity with ISO 13485 and FDA cGMP regulations desirable Ability to lift 40 pounds Salary range - $24.03 - $31.75 (Compensation will vary based on...SuggestedFull time$50k - $75k
...role that are able to daily commute to the ISOutsource Office in Bothell, WA 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...SuggestedWork at officeLocal areaShift workNight shift- ...design software and equipment to perform engineering tasks Develops and maintains Engineering (design and testing) documentation per ISO standards that support the business unit quality system Works with team to develop applications of new communications cabling system...SuggestedInternshipImmediate start
- .../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. Be...SuggestedHourly payFull timeWork at officeRemote work
$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 best...SuggestedFull timeTemporary workPart time$30 - $32 per hour
...others, resolving inventory discrepancies, or conducting root cause analysis is a plus Familiarity with FAA regulations, INCOTERMs, ISO standards, 6S, or similar practices is an advantage Why This Job? Solid Weekly Pay - Direct deposit or payment card, your choice. No...SuggestedHourly payWeekly payFor contractorsWork at officeLocal areaImmediate startShift work$133.56k - $213.7k
...experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), and strong Understanding of all aspects of the QMS related to Design Controls.* You have extensive experience supporting the...SuggestedFull timeWork at officeImmediate startWork visaRelocation package3 days per week$128.52k - $205.63k
...compliance procedures globally, including CE Marking, product registrations, clinical evaluations (in accordance with MDD Annex X), ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, and FDA guidance documents applicable to Philips Ultrasound priorities...SuggestedFull timeWork at officeRelocation package3 days per week$30.5 - $37.5 per hour
...projected product volumes, and product mix. Exhibit a strong sense of safety and of enforcing safe work practices. Ensure that FDA, ISO, OSHA and DOT standards for warehousing, distribution and employee safety are met. Responsible and accountable for carrying out...SuggestedWorldwide- ...government regulations (FDA-Quality System Regulation, and other applicable country specific regulations) and applicable standards (MDSAP, ISO 13485, etc.). This position is responsible for leading and executing the global quality systems and regulatory compliance strategy...SuggestedFull timeTemporary workPart timeWork experience placementWork at officeLocal area
- ...project Instrumentation support to Construction and Start Up personnel as required. Maintain project files of previous revisions per ISO 9001 policies. Personal Expectations Have the ability to work independently with moderate supervision upon assignment of tasks....SuggestedHourly payFull timeContract workWork at officeRemote work
$110k - $130k
...control processes including specifications, inspection, supplier control, production control and quality control processes. Understands ISO, GMP regulatory requirements. Understands Oracle and DataSweep or other electronic device history record system. Skills/Abilities...SuggestedContract work$128.52k - $180k
...knowledge of FMEAs and RMRs, Minimum 3 years’ prior management or other relevant experience, Experience with FDA inspection, and/or ISO Audits, NCR, FSN and CAPA experience is a plus, Experience in both medical and non‑medical is a plus, Working knowledge of cGMP, FDA...Full timeWork at officeImmediate startRemote workWork visaRelocation package3 days per week$128.52k - $180k
...knowledge of FMEAs and RMRs, Minimum 3 years’ prior management or other relevant experience, Experience with FDA inspection, and/or ISO Audits, NCR, FSN and CAPA experience is a plus, Experience in both medical and non-medical is a plus, Working knowledge of cGMP, FDA...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$102.48k - $163.97k
...regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Controls, knowledge of Risk Management (ISO 14971), SDLC and experience in Mobile Applications and/or SaMD is preferred. You have proven experience in Software Design...Full timeWork at officeImmediate startWork visaRelocation package3 days per week- ...with quality standards. Candidates should have a high school diploma and related experience, particularly in PCBAs and familiarity with ISO 13485 and FDA regulations. This position offers a competitive salary, annual bonus potential, and comprehensive benefits including...
$73.1k - $98.9k
...experience working with quality systems (e.g. Boeing Quality Management System (BQMS), International Organization for Standardization (ISO 9001), Aerospace Standard (AS9100) Preferred Qualifications (Desired Skills/Experience): 3+ years of experience in defining,...Permanent employmentFull timeInterim roleRelocationVisa sponsorshipWork visaRelocation packageFlexible hoursShift workDay shift$115k - $158k
...certificates. Integration with Medical Device Regulatory & QMS Collaborate with Regulatory Affairs and Quality to ensure alignment with ISO 13485, design controls, and change management processes. Support regulatory submissions and technical documentation by providing...Temporary workRemote workFlexible hours$97k - $125k
...safety, and EMC is strongly preferred. ~2+ years leadership role working with line departments in a manufacturing environment. ~ ISO, FDA, or other regulated industry training and experience. ~ Risk assessment experience. Skills/Abilities: Excellent written...Full time$97k - $120k
...area of the project. Must have excellent technical writing skills to develop electronic module qualification plans and reports. ISO, FDA or other regulated industry training and experience are highly desired. Industry exposure to international contract...Full timeContract work$57.64k - $115.17k
A leading aerospace company is seeking a Quality Assurance Engineer in Monroe, Washington, to ensure compliance with FAA regulations and quality standards. You will develop and implement a robust quality management system, conduct audits, and analyze performance data to...$181k - $288.96k
...the right fit if: You have a minimum of 10+ years’ experience in Product Design Quality/Control with extensive experience in both ISO 13485 Medical Device/Technology and ISO 9001, with extensive design/development experience in Class I medical device, consumer goods...Full timeWork at officeImmediate startWork visa3 days per week$104k - $115k
...reliability software tools, such as Reliasoft, Weibull++, Minitab. Experience with the following standards is preferred, but not required: ISO 14971, IEC 60601-1, IEC 60601-2-37. In-depth understanding of both hardware and software for integrated products, including a...Full time$123k - $170k
...collaboratively with a multi-disciplinary product development team in accordance with the standards IEC 14971, IEC 60601, IEC 62366, and ISO 13485. Principal Responsibilities and Duties: Note: The following is meant to be representative but not necessarily all...Full timeTemporary workWorldwideFlexible hours$330.69k - $400.72k
...therapy manufacturing. Work effectively with US FDA and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ISO and other applicable standards. Drive continuous improvement and foster an operational excellence culture. Critical Leadership...Hourly payPermanent employmentFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$25.2 per hour
...with international shipping (preferred). Experience working within a rigorous, quality control environment such as FDA cGMP/QSR or ISO. A strong team player with demonstrated abilities and willingness to wear multiple hats, to perform a wide range of tasks (from...Hourly payFull timeTemporary workLocal areaRemote workMonday to FridayWeekend workWeekday workKelly Services, Inc.
Bothell, WA1 day ago$145k - $170k
...operating systems including Windows embedded and Microsoft software development tools (Visual Studio) is desired ~ Experience with ISO, FDA, or other regulated product development environments strongly desired Skills and Abilities: Excellent analytical and problem...Full time
