{"schemaVersion":"jobsearcher.job.v1","id":"6ddc6a6f2e9f3c2a996e17cf","url":"https://jobsearcher.com/jobs/6ddc6a6f2e9f3c2a996e17cf","canonicalUrl":"https://jobsearcher.com/jobs/6ddc6a6f2e9f3c2a996e17cf","title":"Quality Engineer, Sustaining","description":"The Quality Engineerwill join our Quality Engineering team, focusing on product sustaining. This role is responsible for supporting the manufacture of high quality implantable and non-implantable spine surgery medical devices by ensuring compliance with contractual and regulatory requirements. Working closely with our NPI QE team, contract manufacturers and quality control, you will ensure only good product goes on shelve. Activities involves assessing incoming inspection methods and sampling, process controls at the contract manufacturers, facilitating nonconforming material report investigation and closure, failure investigations, CAPA and SCAR ownership, and change control activities. This role liaisons with R&D, Quality NPI, Supplier Quality, Supply Chain and Regulatory and includes continuous improvement projects.\n\nEssential Duties and Responsibilities\n\nSupport Material Review Board (MRB).\n\nDevelop and revise inspection methods, gages and associated drawings and procedures.\n\nSupport Engineering Change Order Review.\n\nPerform Design For Manufacturing activities (DFM).\n\nTechnical interface with contract manufacturing\n\nSupport suppliers in performing IQ, OQ and PQ processes\n\nProvide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.\n\nLead Risk Management efforts in accordance with ISO 14971.\n\nLead continuous improvement projects\n\nParticipate in FDA, ISO, and other regulatory audits.\n\nOther duties as assigned.\n\nTechnical\n\nKnowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485), and other applicable standards.\n\nExperience supporting on-market / commercialized product\n\nKnowledge of mechanical inspection methods and equipment\n\nKnowledge of SPC, DOE, probability, and statistics\n\nAbility to read, analyze, and interpret blueprints and GD&T\n\nAbility to solve complex problems to root cause and prevent re-occurrence (CAPA)\n\nProficient in Technical Writing (Protocols, Reports)\n\nKnowledge of Solid Works or other CAD software\n\nWorking knowledge of biocompatibility requirements\n\nThe ability to execute plans/strategies to completion\n\nProject management and communication with internal and external customers\n\nPersonal Attributes:\n\nSelf-starter, works independently and maintains positive, enthusiastic attitude with a high-level of attention to detail/quality.\n\nAbility to handle competing priorities and a broad variety of tasks simultaneously under high pressure and ambiguity.\n\nStrong facilitation skills, confident communicator (both verbally and written) with all levels of organization and diverse audiences.\n\nAbility to develop and maintain strong working relationships with internal and external customers and suppliers.\n\nAbility to have good decision-making skills and judgment.\n\nMust be able to travel up to 10% of the time to Alphatec Spine, Inc. facilities and suppliers.\n\nEducation and Experience\n\nMinimum Bachelor’s degree (BS) from a four-Year College or university in Mechanical, Industrial and Systems, Biomedical, or Manufacturing Engineering.\n\n3+ years related experience and/ or training; or equivalent combination of education and experience.\n\nCertificates, Licenses, registrations\nSix Sigma Black Belt, ASQ CQE/OE (Certified Quality Engineer/Operational Excellence), preferred.\n\nFor roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).\n\nATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.\n\nSalary Range\nAlphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $75,000 to $90,000 Full-Time Annual Salary\n\nPlease Note: At this time, we are unable to sponsor employment visas.\n\nBenefits\n\nHealth Care Plan (Medical, Dental & Vision)\n\nRetirement Plan (401k, IRA)\n\nLife Insurance (Basic, Voluntary & AD&D)\n\nPaid Time Off (Vacation, Sick & Public Holidays)\n\nFamily Leave (Maternity, Paternity)\n\nShort Term & Long Term Disability\n\nFree Food & Snacks\n\nStock Option Plan\n\n#J-18808-Ljbffr","company":"Internetwork Expert","rawCompany":"internetwork expert","city":"Carlsbad","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-06-17T04:16:59.589Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer, Sustaining","description":"The Quality Engineerwill join our Quality Engineering team, focusing on product sustaining. This role is responsible for supporting the manufacture of high quality implantable and non-implantable spine surgery medical devices by ensuring compliance with contractual and regulatory requirements. Working closely with our NPI QE team, contract manufacturers and quality control, you will ensure only good product goes on shelve. Activities involves assessing incoming inspection methods and sampling, process controls at the contract manufacturers, facilitating nonconforming material report investigation and closure, failure investigations, CAPA and SCAR ownership, and change control activities. This role liaisons with R&D, Quality NPI, Supplier Quality, Supply Chain and Regulatory and includes continuous improvement projects.\n\nEssential Duties and Responsibilities\n\nSupport Material Review Board (MRB).\n\nDevelop and revise inspection methods, gages and associated drawings and procedures.\n\nSupport Engineering Change Order Review.\n\nPerform Design For Manufacturing activities (DFM).\n\nTechnical interface with contract manufacturing\n\nSupport suppliers in performing IQ, OQ and PQ processes\n\nProvide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.\n\nLead Risk Management efforts in accordance with ISO 14971.\n\nLead continuous improvement projects\n\nParticipate in FDA, ISO, and other regulatory audits.\n\nOther duties as assigned.\n\nTechnical\n\nKnowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485), and other applicable standards.\n\nExperience supporting on-market / commercialized product\n\nKnowledge of mechanical inspection methods and equipment\n\nKnowledge of SPC, DOE, probability, and statistics\n\nAbility to read, analyze, and interpret blueprints and GD&T\n\nAbility to solve complex problems to root cause and prevent re-occurrence (CAPA)\n\nProficient in Technical Writing (Protocols, Reports)\n\nKnowledge of Solid Works or other CAD software\n\nWorking knowledge of biocompatibility requirements\n\nThe ability to execute plans/strategies to completion\n\nProject management and communication with internal and external customers\n\nPersonal Attributes:\n\nSelf-starter, works independently and maintains positive, enthusiastic attitude with a high-level of attention to detail/quality.\n\nAbility to handle competing priorities and a broad variety of tasks simultaneously under high pressure and ambiguity.\n\nStrong facilitation skills, confident communicator (both verbally and written) with all levels of organization and diverse audiences.\n\nAbility to develop and maintain strong working relationships with internal and external customers and suppliers.\n\nAbility to have good decision-making skills and judgment.\n\nMust be able to travel up to 10% of the time to Alphatec Spine, Inc. facilities and suppliers.\n\nEducation and Experience\n\nMinimum Bachelor’s degree (BS) from a four-Year College or university in Mechanical, Industrial and Systems, Biomedical, or Manufacturing Engineering.\n\n3+ years related experience and/ or training; or equivalent combination of education and experience.\n\nCertificates, Licenses, registrations\nSix Sigma Black Belt, ASQ CQE/OE (Certified Quality Engineer/Operational Excellence), preferred.\n\nFor roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).\n\nATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.\n\nSalary Range\nAlphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $75,000 to $90,000 Full-Time Annual Salary\n\nPlease Note: At this time, we are unable to sponsor employment visas.\n\nBenefits\n\nHealth Care Plan (Medical, Dental & Vision)\n\nRetirement Plan (401k, IRA)\n\nLife Insurance (Basic, Voluntary & AD&D)\n\nPaid Time Off (Vacation, Sick & Public Holidays)\n\nFamily Leave (Maternity, Paternity)\n\nShort Term & Long Term Disability\n\nFree Food & Snacks\n\nStock Option Plan\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T04:16:59.589Z","dateModified":"2026-06-17T04:16:59.589Z","hiringOrganization":{"@type":"Organization","name":"Internetwork Expert","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Carlsbad","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"6ddc6a6f2e9f3c2a996e17cf"},"url":"https://jobsearcher.com/jobs/6ddc6a6f2e9f3c2a996e17cf"}}