QA Validation Engineer - Medical Devices PQ & Method
Katalyst-Healthcares-
Katalyst-Healthcares- is seeking a QA Validation Engineer to support quality assurance, process validation, and test method validation in a regulated medical device environment. The candidate will apply PQ and method validation expertise and work with CAPA processes to maintain compliance.
The role requires hands-on experience in validation activities, strong knowledge of FDA regulations, GMP, and ISO 13485, and collaboration across QA, Manufacturing, Engineering, and Regulatory teams.
#J-18808-Ljbffr- ...Summary We are seeking a qualified QA Validation Engineer to support quality assurance, process validation, and test method validation activities within a regulated medical device manufacturing environment. The... ..., Performance Qualification (PQ), and Method Validation, along...Suggested
- ...Remote50% RemoteSummaryThe Systems Engineer will support the overall technical... ...integration, and verification/validation within a regulated medical device environment.Roles & Responsibilities... ...or UMLUnderstanding of statistical methods (DOE, sampling, etc.)Strong analytical...Suggested
- ...are seeking an experienced Validation Engineer to support validation activities... ...within a regulated medical device environment. The ideal candidate... ..., review, and execute IQ/OQ/PQ validation protocols and reports... ....Apply statistical methods and data analysis to evaluate...Suggested
- ...experienced CSV (Computer System Validation) Engineer to join our team in Plymouth... ...URS, FS, DS, IQ, OQ, PQ, and validation summary reports... .... Collaborate with QA, IT, Engineering, Manufacturing... ...within pharmaceutical, biotech, medical device, or other regulated environments...Suggested
- ...Captures RJG data & defines validated process windows Updates PODs... ...FW redlines Prepares draft OQ/PQ plans Coordinates daily with... ...readiness Qualification: Mold engineer -Mold qualification skills required... ...in Mold Validation role in Medical Device Industries. Healthcare....Suggested
- ...Summary:We are seeking an experienced Test/Validation Engineer with expertise in manufacturing... ...experience in LabVIEW, NI Test Stand, IQ/OQ/PQ validation, functional testing, and... ...in regulated environments such as Medical Devices, Life Sciences, Pharmaceutical, or FDA...
- ...Freudenberg Medical LLC in Minnesota is seeking a qualified engineer to lead development, prototyping, testing, and documentation for new medical devices. You will drive NPI initiatives from concept... ...manufacturing processes, perform IQ/OQ/PQ validations, and contribute to risk...
$135k - $157.5k
...Staff Supplier Quality Engineer- Contract Manufacturing... ...California-based global medical device company dedicated to... ...equipment, tooling, test method, facility, and manufacturing... ...risk-based process validation and transfer strategies, including IQ/OQ/PQ or PPQ, validation...Contract workFor contractorsLocal areaWork from homeFlexible hours- ...As a Senior Systems Verification and Validation Engineer (contract) on Vantive's Acute Therapies... ...will also develop and improve test methods, validate those methods, support test... ...software-controlled systems, particularly medical devices developed under the rigor of a...Contract workImmediate start
- Experis Technology Group is seeking a Failure Analysis Engineer I in Plymouth, MN to conduct investigations of returned medical devices, performing electrical, functional, mechanical, and visual evaluations. You will develop strategies, execute root cause analysis, and...
$102.4k - $179k
...Responsibilities:Design and execute quality engineering strategies for AI-powered applications,... ..., reusable testing accelerators, validation processes, and automated workflows that... ...validation datasets and quality evaluation methods.Advance AI-assisted testing and modern...Full time- Primary Talent Partners has a new contract opening for a Quality Engineer I with our medical device client in Plymouth, MN. This is a 12-month contract with a potential for extension. The role involves overseeing quality standards, collaborating with engineering and manufacturing...Contract work
- ...White Bear Lake, MN offers an 8-month Process Development Engineer Co-Op on-site, focusing on implantable systems... ...experienced engineers. Responsibilities include developing and validating processes, methods, data analysis, and continuous improvement to optimize yields...
$124.7k - $187k
...and Process Development Engineering Teams significantly... ...characterization and validation efforts to meet strict... ...advanced statistical methods and Design of Experiments... ...Performance Qualifications (PQ) for specialized... ...hands-on experience in medical device manufacturing/process...Local area- ...generation production and manufacturing methods leverage AI, IoT, automation, wearables,... ...realizing complex large scale manufacturing engineering initiatives. This includes... ...competitive suite of benefits including medical, dental, vision, life, and long-term disability...Full timeWork experience placementLive inWork at officeLocal area
$94.14k - $134.63k
...this organization, the Advanced Surface Engineering team focuses on surface science, interface... ...as XPS, XRF, AFM, and related metrology methods to evaluate chemistry, contamination,... ...participate in discretionary bonus program, medical, dental, vision, and life insurance,...Full timeTemporary workFlexible hours$100.8k - $165.6k
...Position Summary: The Senior Manufacturing Engineer is responsible for planning, designing... ..., FAT/SAT, and full lifecycle validation (IQ/OQ/PQ). Lead cross-functional initiatives with... ...insurance benefits starting on day one: medical, dental, vision, life, short-term...Full timeTemporary workInternshipWork at officeWorldwideFlexible hours- ...seeking a Research & Development Engineering Intern for the Maple Grove,... ...and prototyping new device concepts and supporting the development... ...of next-generation medical devices. You will work with the... ...hands-on experience in test methods, data analysis, and cross-functional...Internship
- ...leader to own the software lifecycle for regulated medical device software. You will drive SDP, SRS, architecture, DFMEA... ...will shape architecture, select tech stacks, mentor engineers, and lead verification/validation across complex systems while aligning with cross-...
- A Test Engineer II opportunity is available for an onsite role supporting cardiac device products. The position focuses on developing and validating test methods, with a strong emphasis on electrical engineering... ...Experience in supporting medical device products,...
- ...development and process validations including IQ/OQ/PQ, drafting protocol/reports... ...layouts using statistical methods. Design and implement... ...Mechanical or Industrial engineering, or equivalent, plus. 5&plus... ...Engineer, preferably in Medical Devices. Experience using statistical...
$83k - $124.6k
...connected world. Job OverviewTE’s Medical business unit, part of the... ...segment, offers medical device OEMs a completeproduct... ...therapeuticdevices.With more than 350 design engineers and a global presence in all... ...capabilityassessments, test method validations, and characterization...Local area$103.2k - $154.8k
...first — developing innovative medical technologies that improve the... ...NMPH Advanced Manufacturing Engineering function, supporting the development... ...implantable medical devices. The team partners closely with... ...characterization studies, and test methods to establish process windows...Full timeH1bWork at officeLocal areaImmediate startFlexible hours- ...to produce components for the medical device and aerospace industries. Our Manufacturing Engineers provide engineering support to... ...translate innovative concepts into validated, manufacturable medical... ...(AM Machines, CNC, inspection methods, and properties of materials)Experience...Full timeTemporary work
- ...specifically those having a medical application. We treat... ...and finished device as though it will be used... ...mission of the Senior Engineer, Validation is to ensure that our... ...Cleaning Validation (PQ/PPQ) On average, this... ...and analytical sampling methods. Strong statistical...Local areaFlexible hoursShift work
$93k - $117k
...USMatrix Technologies is a 100% employee-owned engineering, construction, automation, and digital... ..., and related plant-floor connectivity methods.Knowledge of process control network... ...boundaries.Commissioning or supporting validated, regulated, or quality-sensitive manufacturing...Full timeWork at officeLocal areaImmediate startWork from homeFlexible hoursNight shift$94.14k - $134.63k
About our group:The Equipment Engineering team is helping lead Seagate's transformation to an... ...data and structured problem-solving methods to improve system reliability, availability... ...participate in discretionary bonus program, medical, dental, vision, and life insurance,...Full timeTemporary workFlexible hours$100.8k - $165.6k
...applications. The Senior Manufacturing Engineer - Productivity leads hands-on productivity... ..., and other manufacturing-productivity methods. Experience leading cross-functional improvement... ...insurance benefits starting on day one: medical, dental, vision, life, short-term...Full timeTemporary workInternshipWorldwideFlexible hours- ...efficiency. The Senior Advanced Manufacturing Engineer applies technical expertise with... ..., and reviews processing techniques and methods applied in the manufacture, fabrication,... ...Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee...Local area
- ...A global staff augmentation firm is seeking a Principal Supplier Engineer in Arden Hills, Minnesota. This critical role involves bridging technology integration within the supply chain for medical devices. Responsibilities include leading project teams and ensuring compliance...
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