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Provides CAPA, complaints, audit and overall QMS support in regards to software. Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology.
$110,000 - $135,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Functional accountability for this role includes: Quality System Management, Management Review, Q&C Metrics, NC/CAPA management, Document and Change Control, Records Management, IT Quality Systems, Quality Planning, Design Control, Risk Management, Internal/External Standards, Escalation/Field Actions, Training, and QA Analytics and Solutions, for JJV.
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Support NCR and CAPA activities by performing investigations and recommending countermeasures. Can program MS Excel Macros, Minitab and PowerBi 1 years of experience using SolidWorks Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
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Lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing, and quality metrics data analysis. Support various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Leads investigation of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Quality Management, Medical Device, Regulatory Standards, Quality Compliance, CAPA / NC. Knowledge on NC, CAPA, Audit processes. Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.
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Maintains compliance of quality related logs and records, including but not limited to, CAPA, NCR, ASL, CAL/PM, and Training. Maintains compliance of quality related logs and records, including but not limited to, CAPA, NCR, ASL, CAL/PM, and Training.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provide CAPA, complaints, audit and overall QMS support in regards to software. Provide CAPA, complaints, audit and overall QMS support in regards to software. In this role, the Senior QA Engineer will be responsible for leading the ongoing implementation of Software Quality Management System (QMS) through the integration of internal and external/medical device industry best practices.
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Demonstrated knowledge of AWS architecture and tools (EC2, Lambda, RDS, Dynamo DB, RedShift, SQS, S3, API Gateway, Kinesis, and CloudWatch). Previous experience with digital health, Health IT or mobile medical applications required.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Proficient computer skills including MS Word, Excel, and statistical software (e.g., MiniTab, Statgraphics, Design of Experiment DOE, etc. Production Support Focus Lead quality engineering projects to support the manufacturing of medical devices.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Assists with customer complaints/CAPA system. Represents regulatory affairs on product development and commercialization teams. Job Title: Regulatory Affairs SpecialistJob Responsibilities:This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.
$80,000 - $120,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Tracks timelines and documents milestone achievements for inclusion in regulatory submissions. Reviews documents for regulatory claims, promotional material, labeling content, product and process changes, and product documentation.
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Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files). For California, the base pay range for this position is $80,000 to $120,000 (highly experienced.
$120,000 - $160,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Supports ongoing effort of process improvement activities such as CAPA and/or procedure updates. The Document Control Specialist position provides administrative and operational support to Document Control.
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Familiar-working knowledge with ASTM/ISO/FDA CAPA and Qualification-Validation/Audit procedures. Observe and support Herbalife Nutrition Safety, Ethics and Compliance polices. Conduct in-depth technical feasibility assessments on packaging design, including sustainability impact, supply chain, manufacturing, cost drivers, and consumer impact.
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capa job in Laguna Hills, CA
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