Medical Device Quality Engineer - Design Controls
Katalyst-Healthcares-
Job Summary: We are seeking a Quality Engineer with experience in the Medical Device industry to support innovative healthcare products while collaborating with R&D, Regulatory, and cross-functional engineering teams. The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product Development Support. Roles & Responsibilities: Support Medical Device Quality Engineering activities. Collaborate with R&D, Regulatory, and cross-functional engineering teams. Support Design Controls and Risk Management activities. Participate in Verification & Validation (V&V) activities. Support Change Control and CAPA processes. Ensure compliance with GxP requirements. Provide Product Development support. Education & Experience: Bachelor's degree in Engineering or a related field. 2+ years of Medical Device Quality Engineering experience. Strong knowledge of Design Controls, Risk Management, and Regulatory Compliance. Excellent communication and problem-solving skills. #J-18808-Ljbffr Katalyst-Healthcares-
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Medical Device Quality Engineer - Design Controls in Lake Forest, CA vacancy
- Applied Medical, a leading medical device company, is seeking a Quality Engineer I to join our on-site team in California. You will support medical device quality through... ...-functional team. You will collaborate with design and manufacturing to assess device risk, generate...Suggested
$130k - $160k
...We are applying science and engineering to design transformational technologies... ...efficiency, or innovating medical care with a novel cancer treatment... ...development• Development of control and protection algorithms... ...high current systemsPower quality analysis for grid connected...SuggestedFull timeContract workTAE Technologies
Foothill Ranch, CA3 days ago$138k - $180k
...iRhythm Technologies seeks a Senior Automation and Controls Engineer to design and maintain PLC systems, HMI interfaces, and SCADA platforms for manufacturing operations at their Cypress, California facility. The role involves software development, industrial networking...SuggestediRhythm Technologies
Orange, CA9 days ago$85k - $135k
Applied Medical is a new-generation medical device company with a proven business model and... ...delivering the highest quality products, enables team members... ...manufacturing? As a Controls Engineer within our Automation... .... Key Responsibilities: Design and implement electrical...SuggestedLocal areaApplied Medical Resources Corporation
Rancho Santa Margarita, CA5 days ago$96.85k - $132.83k
...Oakley - Quality Engineer Brand: Oakley Location: Foothill Ranch, CA, US, 92610 Position: Full... ...met. We are a global leader in the design, manufacture, and distribution of ophthalmic... ...(i.e MSA, Cpk, SPC, Sampling Plans, Control Plans) Ability to use systematic approach...SuggestedMinimum wageFull timeLocal areaImmediate startEssilorLuxottica SA
Foothill Ranch, CA2 days ago- BioTalent is seeking an experienced Senior Quality Specialist / Quality Engineer for a hands-on role in Foothill Ranch, CA. You will contribute across Operations, Engineering, Customer Service, and Sales to maintain a compliant Quality System. This role emphasizes owning...
$109.14k - $140.01k
...We are a global leader in the design, manufacture, and... ...to a global platform of high-quality vision care products such as... ...FUNCTION The Senior APQP Quality Engineer will be supporting the New Product... ...MSA, Cpk, SPC, Sampling Plans, Control Plans) ~ Excellent customer...Minimum wageFull timeLocal areaEssilorLuxottica Group
Foothill Ranch, CAmore than 2 months ago$100k - $200k
...systems that operate beyond simulation and thrive in unpredictable environments. As our Robotics Autonomy Engineer – Planning and Control , you will design, implement, and deploy advanced motion planning and control algorithms that enable our robots to move with...FieldAI
Irvine, CA20 days ago- An innovative and rapidly growing medical device organization is seeking a Senior Software Quality Engineer to play a critical role in ensuring the quality, compliance... ...software development lifecycle, including design controls, risk management, verification and validation...
Real Staffing Group
Irvine, CA4 days ago - ...Job Title: Design Quality Engineer I Duration: 1+ Year Contract Job Description... ...by ensuring design control processes are robust,... .... Evaluate predicate devices and historical quality data... ...-5 years of experience in medical device product development...Contract work
Kasmo Global
Irvine, CA4 days ago $145k - $190k
ResponsibilitiesMaxLinear is seeking a Principal Analog EDA Design Automation Engineer to join our team. In this role, you will focus on the... ...Programing languages such as Python or PerlKnowledge of version control tools such as perforce, design sync, Method ICExperience...Work experience placementLive inMaxLinear
Irvine, CA6 days ago- Job Summary:Provides design quality engineering guidance and support for New Product... ...(electro-mechanical devices, biocides, detergents, biological... ...and Validation, and Design Control processes. Applies in-depth... ...other regulated industry (medical device, pharmaceutical,...Contract workLocal area
Fortive
Irvine, CA3 days ago $99.2k - $148.8k
...developing innovative medical technologies that improve... ...conditions. Supplier Quality Engineering plays a critical role... ...introductions, design changes, and supplier... ...inspection strategies, control plans, test methods, and... ...Experience in the medical device industry or other highly...Full timeH1bWork at officeLocal areaImmediate startFlexible hoursMedtronic
Irvine, CA5 days ago- ...IntelliPower team, where we design and deliver high-... ...Degree in Electrical Engineering, or a related... ...in Power Electronics, controls, and on-line dual conversion... ...decision-marking, work quality, and to reduce costs.... ...insurance, and family medical leave. ~ Employee referral...Work at officeLocal areaWorldwideFlexible hours
AMETEK
Irvine, CA2 days ago - ...Document Control Specialist I Location: Lake Forest, CA 92630 Duration: 24 months contract Description: The role is responsible... ...or improve existing approaches Preferred: ~3 years in medical device industry within change/document control function...Contract work
Tech Observer
Foothill Ranch, CA2 days ago $81.8k - $118.6k
...professionally at one of the world’s top design firms while building our... .../ Instrumentation & Controls Engineer to join our Energy and... ...reviewing deliverables to ensure quality and consistency.• Coordinating... ...per week) have access to medical, dental, and vision plans, a...Full timeTemporary workPart timeFor contractorsCasual workLocal areaRemote workFlexible hoursStantec
Irvine, CA6 days ago- Blake-Ryan & Associates seeks a senior Controller to lead the accounting function for a fast-growing medical device/manufacturing environment in Lake Forest, CA. This hands-on role covers G/L, cost accounting, and financial reporting, with FP&A support. The ideal candidate...
$164.6k - $263.4k
...Senior Quality Manager, Failure Analysis BD is... ...of the largest global medical technology companies... ...passion of all of us—from design and engineering to the manufacturing... ...~8+ years of medical device industry experience... ...statistical process control, industrial statistical...Work at officeBecton Dickinson
Irvine, CA2 days ago- ...functional stakeholders to provide hands-on quality engineering support across the product... ...contribute to key activities such as design controls, risk management, verification and validation... ...engineering experience in the medical device industry, including direct support...
Katalyst Healthcares & Life Sciences
Lake Forest, CA5 days ago $100k - $120k
Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation... ...to delivering the highest quality products, enables team members to... ...Position DescriptionThe senior machine design engineer, automation leads the design and...Local areaApplied Medical Resources Corporation
Rancho Santa Margarita, CA3 days ago- ...Job Title - Quality Engineer Assignment Duration - 12 Months Location - Irvine, CA 92614... ...quality engineer is to research and test the design, functionality and maintenance of... ...and conduct training sessions on quality control activities. • May specialize in...
Pacer Group
Irvine, CA4 days ago - ...We are a global leader in the design, manufacture, and... ...to a global platform of high-quality vision care products such as... ...FUNCTION The Senior Logistics Engineer is a key leader within Oakley... ...KPIs, dashboards, and process control tools to drive performance and...Minimum wageFull timeFor contractorsWork at officeLocal areaShift work
EssilorLuxottica Group
Foothill Ranch, CA15 days ago $130k - $150k
...improvements in productivity, quality, and operational efficiency.... ...DoingLead automation projects from design through deploymentProgram and... ..., HMIs, robotics, and motion control systemsSupport the... ...vendors, suppliers, and internal engineering teamsProvide technical leadership...CyberCoders
Irvine, CA5 days ago$112k - $145k
...Quality Control Manager At iRhythm, you'll have the opportunity to grow your skills and... ...plans in collaboration with Quality Engineering, Supplier Quality and Manufacturing Engineering... ...years of progressive experience in a medical device manufacturing environment, with...iRhythm Technologies
Orange, CA1 day ago$24 - $30 per hour
Applied Medical is a new generation medical device company with a proven business... ...delivering the highest quality products, enables... ...Leader, Quality Control Inspector leads and... ...including reading engineering drawings and using... ...range of benefits designed to enhance your career...Local areaApplied Medical Resources Corporation
Rancho Santa Margarita, CA6 days ago- ...training and qualifications, and drive safety, quality, and productivity goals across your... ...testing activities to ensure continuous control over material, facilities, and products.Manages... ..., proprietary information, confidential medical records, and other types of highly...For contractorsRelocation
Edison International
Santa Ana, CA5 days ago $146k - $194k
...mission-driven group of manufacturing engineers quality specialists and production operations experts... ...lines implement automated testing design for manufacturing (DFM) and build resilient... ...a plus. Experience flowing down Source Control requirements to Suppliers Working...Full timeContract workWork experience placementImmediate startRelocationAnduril
Santa Ana, CA6 days ago- ...Position Title: Quality Engineer, Staff (Hardware) Department: Quality... ...Senior Manager Enchannel Medical is redefining the boundaries of... ...high impact role in executing design controls remediation for catheter based medical devices, operating within established...Shift work
ENCHANNEL MEDICAL LTD
Irvine, CAmore than 2 months ago $150k - $170k
...applying science and engineering to design transformational technologies... ..., or innovating medical care with a novel... ..., vacuum systems and control layoutsDefine and enforce... ..., and adherence to quality requirements.Monitor... ...large-scale medical devices.Experience working in...Full timeWork at officeTAE Technologies
Foothill Ranch, CA4 days ago- Ambry Genetics Corporation is seeking a highly motivated Manager of Quality Control for the Clinical Lab. Lead the QC department, ensure regulatory compliance, and drive continuous improvement across QC processes and SOPs. This role will work closely with Clinical Lab Operations...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Medical Device Quality Engineer - Design Controls. Be the first to apply!
Related searches
- medical device Lake Forest, CA
- quality Lake Forest, CA
- quality inspection Lake Forest, CA
- water quality Lake Forest, CA
- water quality scientist Lake Forest, CA
- supplier quality Lake Forest, CA
- quality tech Lake Forest, CA
- quality equipment Lake Forest, CA
- quality manufacturing Lake Forest, CA
- quality control lead Lake Forest, CA