Manufacturing Quality Assurance Specialist

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Critical Systems, Inc.

Manufacturing Quality Assurance Specialist

Boise, ID
Full Time
Paid
  • Responsibilities

    ****Why Critical Systems Inc. Is a Great Place to Work

    • Mission-Driven Innovation CSI specializes in cutting-edge gas system and Orbital Welding solutions, meaning your work directly supports industries where precision and safety are paramount. You’ll be part of projects that shape the future of manufacturing and technology
    • Inclusive & Supportive Culture CSI fosters a collaborative and inclusive environment where every voice is valued. Commitment to equity, sustainability, and governance ensures fair access to opportunities and resources for all employees
    • Professional Development You’ll have access to continuous learning and development, helping you stay ahead in quality assurance methodologies and industry standards.
    • Work-Life Balance CSI offers flexible work arrangements, making it easier to maintain a healthy balance between your professional and personal life.

    Job Summary:

    We are seeking a detail-oriented and experienced Quality Assurance Specialist to oversee and improve manufacturing processes in compliance with ISO standards (e.g., ISO 9001, ISO 13485). The ideal candidate will ensure product quality, regulatory compliance, and continuous improvement across production lines.

    Key Responsibilities:

    • Develop, implement, and maintain Quality Management Systems (QMS) in accordance with ISO standards.
    • Conduct internal audits , prepare for external audits, and ensure corrective actions are implemented effectively.
    • Monitor and analyze production processes with spot checks , identifying areas for improvement and ensuring consistent product quality.
    • Collaborate with cross-functional teams (Engineering, Production, Rental-Repair, Supply Chain) to resolve quality issues.
    • Maintain and update Quality Procedures (QPs) and work instructions.
    • Lead root cause analysis and implement corrective actions (CA).
    • Manage non-conformance reports (NCRs) and ensure timely resolution.
    • Train staff on quality standards, procedures, and ISO requirements.
    • Prepare and present quality metrics and reports to management.
    • Help identify competence requirements and provide the required training
    • Work with our internal Quality Management System (QMS) IMSexpress
    • The company reserves the right to add or change duties at any time.

    Qualifications:

    • Bachelor’s degree in Engineering, Manufacturing, or related field a plus.
    • Minimum of 3–5 years of experience in Quality Assurance within a manufacturing environment.
    • Strong knowledge of ISO standards (ISO 9001, ISO 13485, etc.).
    • Experience with auditing , CAPA , and QMS software.
    • Understanding in statistical process control (SPC) and quality tools (e.g., FMEA, 5 Whys, Fishbone Diagram).
    • Excellent communication, analytical, and problem-solving skills.
    • Certification in ISO auditing or Six Sigma is a plus.