• Aptyx (Charlotte, NC)
    …testing, and interpret performance data. Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR 820. Familiarity with relevant ... device specific standards such as ISO 10555, ISO 11070, ISO 5840, ISO 25539, and others. Strong problem solving skills with clear and concise technical… more
    HireLifeScience (12/23/25)
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  • Aptyx (Charlotte, NC)
    …the R&D team Perform cycle counts, audits, and ensure compliance with ISO 13485 inventory controls Collaborate with Purchasing, Engineering, and Production teams to ... communication and teamwork skills Preferred: Experience in a regulated environment (FDA, ISO 13485, GMP) Medical device, electronics assembly, or R&D lab environment… more
    HireLifeScience (12/23/25)
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  • Aptyx (Charlotte, NC)
    …related to fluoropolymers. Experience in medical device development within an ISO 13485 environment. Ability to design experiments, analyze data, and propose ... clear next steps. Strong written and verbal communication skills. Preferred Qualifications Experience with vascular, implantable, or catheter based devices. Prior exposure to supplier qualification and raw material specification development. Familiarity with… more
    HireLifeScience (12/23/25)
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  • Aptyx (Charlotte, NC)
    …is highly preferred to plan and conduct complex development projects within FDA and ISO regulatory requirements. Education BS or MS in Engineering is required PMP or ... other certificated preferred Experience 3+ years experience in engineering for medical devices Experience with concept to commercialization is preferred Skills, Knowledge, and Abilities Strong analytical and problem-solving skills Excellent verbal and written… more
    HireLifeScience (12/23/25)
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  • ValSource, Inc. (Durham, NC)
    …of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO , EU) for validation of GMP facilities. Proficiency with Microsoft office ... including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus. ExperiencePreferred Commissioning, Qualification and Validation (CQV) experience in Pharmaceutical, Biotech, Medical Device or related GMP manufacturing environment preferred. Recent… more
    HireLifeScience (10/27/25)
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  • GRAIL (Durham, NC)
    …in compliance with GRAIL's Quality Management System procedures and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ... applicable regulations and standards, including but not limited to QSR, ISO 13485, CAP/CLIA, NYSDOH, ISO 15189, IVDR. + Experience using an eQMS required; Veeva… more
    DirectEmployers Association (11/13/25)
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  • ALBEMARLE (Charlotte, NC)
    …CAPABILITIES** + Deep expertise in procurement and third-party risk management frameworks ( ISO 31000, COSO, etc.) + Familiarity with risk intelligence platforms (eg, ... preferred). + Experience implementing or operating within procurement risk frameworks ( ISO 31000, COSO). + Familiarity with risk intelligence tools (Resilinc,… more
    DirectEmployers Association (10/30/25)
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  • GRAIL (Durham, NC)
    …document validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485, FDA, and other applicable standards. + Provide scientific and technical ... Deep understanding of clinical laboratory regulatory standards, including CLIA, CAP, NYS, ISO 13485, and FDA. + Experience with or understanding of reagent… more
    DirectEmployers Association (10/24/25)
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  • GRAIL (Durham, NC)
    …traceability and compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 requirements. + Support routine service provider visits, internal and cross-functional ... investigations, and software / firmware upgrades and assessments. + Respond to the Engineering Operations support ticketing system in a timely manner, escalating where appropriate. + Respond to environmental monitoring system alert notifications for cold… more
    DirectEmployers Association (12/04/25)
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  • Renesas (Morrisville, NC)
    …AI/ML, HPC, or Automotive product development cycles and quality standards (eg, ISO 26262, AEC-Q100). + Understanding of product and regulatory certifications (eg ... UL, FCC, CE, UKCA) Additional Information Renesas is an embedded semiconductor solution provider driven by its Purpose ' **To Make Our Lives Easier** .' As the industry's leading expert in embedded processing with unmatched quality and system-level know-how,… more
    DirectEmployers Association (11/18/25)
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