{"schemaVersion":"jobsearcher.job.v1","id":"ff8a98ff9b2475c444993477","url":"https://jobsearcher.com/jobs/ff8a98ff9b2475c444993477","canonicalUrl":"https://jobsearcher.com/jobs/ff8a98ff9b2475c444993477","title":"Quality Engineer","description":"Summary :\nNew Product Development project or legacy product engaged in the development or sustenance of Pharmaceutical Electrophysiology medical device products. Performs ongoing execution of and provides guidance to good manufacturing practices, compliance to internal and external policies and other applicable standards.\n\nRoles & responsibilities :\n\nProvides product team support for multitude of new product development activities (e.g. engineering testing, design and process characterization, and other V&V activities)\n\nAssists in conducting Quality Assurance documentation reviews and audits as needed\n\nSupport execution of risk management activities\n\nSupport development and execution of relevant process development and validation activities (e.g. IQ/OQ/TMV/APQ)\n\nUtilizes multifaceted industry and process excellence standards in daily quality operations, including, but not limited to, good manufacturing practices (GMP) and Good Documentation Practices (GDP)\n\nAssists in addressing product or process issues (internally or externally manufactured) or in investigating customer complaints as needed\n\nSupports handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities.\n\nCollaborate with cross-functional teams to achieve project team goals and objectives\n\nEducation & Experience:\n\nA minimum of a bachelor's degree required (preferably in Engineering or related technical field); or a minimum of 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry\n\nAbility to develop and implement Quality standards\n\nThorough knowledge of Quality systems and processes, including GMP and QSR requirements for medical devices\n\nKnowledge of new product development design controls, and verification and validation (V&V) tools and methodologies\n\nDemonstrated problem solving skills\n\nCompetent in using basic documentation applications such as MS Office (Word, Excel, Powerpoint, Outlook), Adobe PDF, etc.\n\nAbility to multi-task and manage multiple assignments in a timely manner\n\nGood verbal and written communication skills\n\nStrong analytical skills\n\nAbility to apply project management skills to ensure fulfillment of new product development requirements\n\nExperience working in both an FDA and European regulatory environment\n\nExpertise in NPD (New Product Development) process and Design/Process Validation\n\nAmerican Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools\n\nSix Sigma Green/Black Belt Certified\n\nKnowledge of GD&T (Geometric Dimensioning and Tolerancing)\n\nKnowledge of statistical analysis tools such as Minitab is a plus\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Irvine","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-06-17T03:31:26.555Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"Summary :\nNew Product Development project or legacy product engaged in the development or sustenance of Pharmaceutical Electrophysiology medical device products. Performs ongoing execution of and provides guidance to good manufacturing practices, compliance to internal and external policies and other applicable standards.\n\nRoles & responsibilities :\n\nProvides product team support for multitude of new product development activities (e.g. engineering testing, design and process characterization, and other V&V activities)\n\nAssists in conducting Quality Assurance documentation reviews and audits as needed\n\nSupport execution of risk management activities\n\nSupport development and execution of relevant process development and validation activities (e.g. IQ/OQ/TMV/APQ)\n\nUtilizes multifaceted industry and process excellence standards in daily quality operations, including, but not limited to, good manufacturing practices (GMP) and Good Documentation Practices (GDP)\n\nAssists in addressing product or process issues (internally or externally manufactured) or in investigating customer complaints as needed\n\nSupports handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities.\n\nCollaborate with cross-functional teams to achieve project team goals and objectives\n\nEducation & Experience:\n\nA minimum of a bachelor's degree required (preferably in Engineering or related technical field); or a minimum of 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry\n\nAbility to develop and implement Quality standards\n\nThorough knowledge of Quality systems and processes, including GMP and QSR requirements for medical devices\n\nKnowledge of new product development design controls, and verification and validation (V&V) tools and methodologies\n\nDemonstrated problem solving skills\n\nCompetent in using basic documentation applications such as MS Office (Word, Excel, Powerpoint, Outlook), Adobe PDF, etc.\n\nAbility to multi-task and manage multiple assignments in a timely manner\n\nGood verbal and written communication skills\n\nStrong analytical skills\n\nAbility to apply project management skills to ensure fulfillment of new product development requirements\n\nExperience working in both an FDA and European regulatory environment\n\nExpertise in NPD (New Product Development) process and Design/Process Validation\n\nAmerican Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools\n\nSix Sigma Green/Black Belt Certified\n\nKnowledge of GD&T (Geometric Dimensioning and Tolerancing)\n\nKnowledge of statistical analysis tools such as Minitab is a plus\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T03:31:26.555Z","dateModified":"2026-06-17T03:31:26.555Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Irvine","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ff8a98ff9b2475c444993477"},"url":"https://jobsearcher.com/jobs/ff8a98ff9b2475c444993477"}}