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.

• 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.

• 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.
• Initiat…