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Comply with all food and dairy industry, regulatory, and any/all other applicable standards including HACCP, FSMA, PMO, and FDA, and ensure the enforcement of these as they pertain to QA/QC team.
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Our client is currently seeking a Engineer Senior Top 3 Must Have Skill Sets: Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership) Direct experience with regulated environments (FDA, OSHA) with an emphasis on promoting safety and quality in their area of work.
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Ensure safety and quality in all aspects of the job Safely and accurately process Customer products according to established procedures within FDA, ISO, and GMP guidelines. STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.
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Exposure to FDA approved cleaning chemicals (gas, fumes, chemicals). Work with and around tools and equipment, including but not limited to knives, personal protective equipment, forklift, pallet jacks, hand trucks, six-wheel carts, baler, etc.
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Principal Regulatory Affairs Specialist - Structural Heart And Aortic, Mitral And Tricuspid (Hybrid)
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Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, and EU MDR Technical Documentation in addition to Change Management assessments.
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Knowledge of FDA, EU, and Health Canada regulations, guidance, and import/exports requirements for Medical Devices, Natural Health Products and Pharmaceuticals. Proficient in FDA and international regulations (EU and Canada.
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Minimum of 2 years work experience providing document management and record control in an FDA/ISO regulated environment. Biosense Webster is recruiting for an Analyst, Quality Documentation to be located in Santa Rosa, CA.
$76,000 - $121,900 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Responsible for performing required quality control activities as mandated by the Mammography Quality Standards Act (MQSA) and the FDA either as designated Quality Control technologist as under their direction.
$75,000 - $115,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Qualifications Education:Bachelor's degree in Mechanical Engineering, Bioengineering from a four-year college or university; or related major in Life Sciences preferredExperience:Five years with a Bachelor's degree, Three years with a Master's degree in medical device manufacturing, development, testing, or designing, GMP, FDA, and ISO requirements and experience writing protocols, test plans, test reports, design control regulation and experience with catheter and stents preferred.
$100,000 - $130,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position is required to perform a variety of radiological technical procedures specific to the diagnosis and treatment of breast disease in an outpatient setting, either fixed or mobile, functioning in a lead capacity.
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