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Quality Engineer | Quality Engineer in Quality Assurance Job at Aktiv Pharma Group in Broomfield C1

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Quality Engineer

Broomfield, CO

Aktiv Pharma Group is hiring for a Quality Engineer . We are a fast-growing company focused on addressing unmet medical needs through a proprietary drug delivery system. Aktiv Pharma Group is a direct contractor of the United States Federal government and subject to the requirements of the Executive Order 14042. Prior to submitting your application for employment, we recommend reviewing the requirements of Executive Order 14042. The Quality Engineer (QE) is involved in the development, implementation, and maintenance of the quality engineering methodologies, systems, and practices which meet FDA Medical Device/Combination Product regulatory standards concentrating on the application of NPD Manufacturing Integration and Design Controls for pre-commercial devices.At Aktiv Pharma Group, we value the diversity of perspectives and backgrounds our employees bring. We are committed to achieving a diverse workforce through application of our equal opportunity employment policy and by providing a work environment free of discrimination and harassment. We work according to our values of truth, caring, goodness and perseverance, and encourage individuals with the required skill-sets and these values to apply.The compensation range for the Quality Engineer is $75,000 - $130,000 annually. Essential Duties/Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Builds and supports the Quality Engineering function by providing intelligence, discipline, problem solving and collaborative skills that can improve designs and processes. Authors and/or maintains implementation of Design Controls into manufacturing process throughout early product development and design transfer phases. Supports development Design Control portion of the Quality Management System (QMS) that encompasses all the Standard Operating Procedures (SOPs) that are required by the Federal Drug Administration (FDA) for medical device/combination products. Investigates non-conforming events and product failures using as they relate to Design Controls to drive product and process improvements with the objective of compliance safety and high customer satisfaction. Establishes and applies statistical analysis and controls tools throughout product development and manufacturing processes. Ensures risk management is effective by using feedback from validation, field service, post market surveillance, manufacturing indicators, corrective and preventative actions (CAPAs), etc., including maintaining the risk management SOP. Supports Equipment qualification, Process Validation (IQ, OQ, PQ), and Design Validation and Verification (V&V) activities including writing, reviewing, and approving of plans and/or protocols/reports. Oversees and/or works closely with impacted departments to ensure that any changes to the Design History File (DHF) are reviewed by subject matter experts including the QE and are captured appropriately within the QMS System. Supports Reliability Engineering including the FDA's reliability of 99.999% (“5-9s”) for emergency use products and integration into sustainable manufacturing controls. Reviews/ approves SOPs in the QMS, EHS, and other technical areas as the Quality representative. Supports the implementation of continuous improvement activities to improve Aktiv’s QMS . Other duties as required and necessary to ensure the success of the organization. Job Qualifications Competencies, Knowledge, Skills, and Abilities: Ability to consistently promote, support, work, and act in a manner in support of Aktiv's mission, vision and values. Strong ability for application and leading problem-solving, root cause analysis and related CAPA. Must be able to interface well with others, especially Manufacturing Engineering, Research and Development (R&D) Engineering, and Regulatory. Experienced with statistical techniques, preferred familiarity with six sigma methodologies and statistical process control; able to analyze results. Ability to work independently, with excellent organizational, communication, leadership and problem-solving abilities . Comprehensive knowledge of product development life cycle and design transfer. Extensive knowledge of methods and process of medical device design controls. Well-versed in the methodologies of V&V, and FDA (21CFR 803/806/820). Sound knowledge of manufacturing equipment equipment, drawings, ISO (ISO: 13485) regulations, Gage R&R, and advanced engineering concepts. Familiarity with Risk Management implementation per ISO 14971. Well-versed in communicating effectively with knowledge of basic computer applications. Experience with new pharmaceutical and/or medical device product development (combination product preferred but not required) Proficient understanding of Medical Device QSR and ISO 13485. Education or Formal Training : A Bachelor’s degree with CQE experience or BS in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline is required. Experience : Three (3) to seven (7) years experience in a pharmaceutical or medical device environment is required with a portion of that directly involved in new product development or new product integration is preferred. An equivalent combination of education and experience may be substituted on a year to year basis. Additional Requirements/Licenses/Certifications: ASQ (American Society for Quality) certified or Certified Quality Engineer or equivalent is preferred. Must have reliable transportation. Valid driver’s license. Powered by JazzHR
Aktiv Pharma Group
September 23 on The Resumator
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Quality Engineer is a Quality Assurance Quality Engineer Job at Aktiv Pharma Group located in Broomfield CO. Find other listings like Quality Engineer by searching Oodle for Quality Assurance Quality Engineer Jobs.