Quality Inspector

Job Responsibilities Perform Quality Control inspection activities related to THV manufacturing, including functional inspection, visual inspection, final inspection, packaging inspection, and final release activities, in accordance with approved procedures and production requirements. Support day‑to‑day QC inspection priorities by completing assigned inspection tasks accurately, efficiently, and in alignment with production schedules. Review in‑process and finished product documentation, including manufactured valve DHRs, Jasmine preparation records, inspection records, and ancillary logs, to ensure completeness, accuracy, and compliance with Good Documentation Practice (GDP) requirements. Support review and release activities for THV Device History Records and final product release documentation in accordance with established quality requirements. Identify, document, and communicate inspection discrepancies, documentation errors, nonconforming material, or quality concerns in a timely manner to QC supervision, Quality Engineering, Manufacturing, or other applicable functions. Support Material Review Board (MRB) activities by providing inspection results, documentation review input, and product status information related to nonconforming material. Perform inspection‑related activities in support of Engineering, R&D, validation, process development, and special projects, as assigned. Assist with training, onboarding, and qualification of QC Inspectors by providing hands‑on guidance, procedure walkthroughs, inspection technique support, and feedback, as appropriate. Maintain certification and qualification for applicable QC inspection activities, including functional, visual, final inspection, packaging, and release‑related processes. Support adherence to Good Manufacturing Practices (GMP), Good Documentation Practice (GDP), document control, record retention requirements, and applicable Quality Management System procedures. Verify that inspection equipment, tools, fixtures, and work areas are ready for use, properly maintained, and within calibration or preventive maintenance requirements before use. Support preventive maintenance and calibration coordination for QC equipment, including Vivitro, BDC, or other inspection/test systems. Provide clear and timely communication to QC supervision and cross‑functional stakeholders regarding inspection status, documentation issues, product holds, release status, training needs, and quality concerns. Serve as a technical resource for QC inspection processes, demonstrating strong procedural knowledge, attention to detail, and consistent application of acceptance criteria. Ensure compliance with site Health & Safety requirements and maintain safe working practices within QC inspection areas. Support broader business and departmental objectives as needed and perform other duties as assigned within the scope of the role. Maintain reliable and consistent attendance to support production operations, including punctual arrival and the ability to work full scheduled shifts and overtime as required to meet operational and production needs. Required Education and Experience Level of role determined by experience, technical skills, and demonstrated competencies relevant to the position. High school diploma or equivalent required. Candidates without a diploma may demonstrate equivalent competency through a validated external assessment. Experience in Quality within medical devices or pharmaceutical industries is desirable. Familiarity with 21 CFR 820 and ISO 13485 requirements; hands‑on experience preferred. Experience assessing products for compliance and final release is required. Skills and Abilities Required for This Job Technical proficiency in maintaining production quality, supporting team development, and ensuring consistent process execution. Ability to work effectively and collaborate within cross‑functional teams. High attention to detail and ability to handle multiple tasks. Proficiency at filing and organizing records in a compliant, easily retrievable manner. Strong verbal and written communication skills, articulating results and conclusions. Good documentation skills. Initiative, autonomy, and prioritizing workload. Proficiency with standard MS Office applications (Word, Excel, PowerPoint). Read, comprehend, and speak English. Physical Requirements Work in a controlled cleanroom environment while wearing full cleanroom gowning (gown/coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed). Prolonged periods of standing and sitting to support inspection, testing, and review activities. Follow clean rooms, laboratory, and site safety protocols at all times. Use inspection and testing equipment as part of routine job duties. Perform work involving close visual attention and detailed product inspection. International travel may be required. Perform physical movements such as push, pull, twist, climb, balance, stoop, kneel, crawl. Perform repetitive motions such as reaching and grasping. Ability to lift or move materials up to 25 pounds. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status. Kelly complies with the provisions of California’s state and local Fair Chance laws and participates in E‑Verify. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. #J-18808-Ljbffr Kelly Services