Quality Assurance Manager - Glenview - SpotSee

    SpotSee
    SpotSee Glenview

    1 day ago

    $65,000 - $115,000 (USD) per year * Transportation / Logistics
    Description

    POSITION:    Quality Manager REPORT TO:       Global Quality & Regulatory Mgr.

    LOCATION:     Glenview, IL DEPARTMENT:  Quality Engineering Salary: 80K-85K

    ROLE DESCRIPTION:

    Responsible for ensuring compliance with and adherence to ISO 13485 standard and FDA 21 CFR 820. Maintains registration of FDA Class 1 and Class 2 devices. Formulate and implement corrective / preventative actions to resolve customer complaints or non-conformances and perform root cause analysis. Oversee internal quality KPIs and audits. Host external audits (customer, ISO registrar, FDA). Develop and initiate standards and methods for inspection, testing, and/or evaluation. Formulate and maintain quality objectives and coordinate them with procedures and other disciplines. Participate in the planning and design of quality procedures.

    KEY RESPONSIBILITIES:

    1.    Quality Management Systems:

    ·       Establish and maintain robust quality management systems (QMS) that align with applicable FDA and ISO requirements and support organizational objectives.

    ·       Develop and implement quality policies, procedures, and work instructions to ensure adherence to regulatory standards and best practices.

    ·       Supervise regular internal audits and management reviews to evaluate the effectiveness of the QMS and identify opportunities for improvement.

    2.    Regulatory Compliance:

    ·       Stay current with FDA regulations, ISO standards, and other relevant guidelines applicable to the organization's products or services.

    ·       Develop and implement strategies to ensure compliance with FDA regulations and ISO Quality Management for Medical Devices).

    ·       Coordinate and manage FDA inspections, ISO audits, and other regulatory assessments, ensuring prompt response and resolution of findings.

    3.     Product Quality Assurance:

    ·       Monitor and analyze product quality metrics, complaint trends, and non-conformance incidents to implement corrective and preventive actions.

    ·       Collaborate with product development teams to integrate quality considerations into the design, development, and manufacturing processes.

    ·       Implement corrective and preventative actions based on nonconformances and/or complaints.

    4.    Risk Management:

    ·       Develop and maintain risk management plans and strategies to address potential hazards, failures, or adverse events related to products or processes.

    ·       Assist with and implement risk assessments, FMEA (Failure Mode and Effects Analysis), and other risk management activities to proactively manage risks throughout the product lifecycle.

    ·       Identify, assess, and mitigate risks associated with product quality, regulatory compliance, and business operations in accordance with FDA and ISO standards.

    5.    Cross-Functional Collaboration:

    ·       Collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain to foster a culture of compliance, accountability, and continuous improvement, and to ensure alignment of quality and regulatory objectives with business goals.

    ·       Implement and maintain process validation documents

    ·       Conduct training and development programs to enhance the knowledge, skills, and capabilities of staff members involved in quality and regulatory activities.

    REQUIREMENTS

    EDUCATIONAL BACKGROUND:

    ·       Bachelor's degree in chemistry, engineering, general science or quality is required (chemistry, chemical or material engineering preferred) or equivalent experience.

    ·       Familiarity with LEAN / Six Sigma tools

    EXPERIENCE:

    ·       Five years of experience in a similar position.

    ·       Experience in the application of quality systems.

    ·       Effective communication and negotiation skills.

    ·       Experience implementing improvements and LEAN / Six Sigma methodologies in manufacturing processes.

    ·       Experience in problem-solving techniques.

     

    SKILLS:

    ·       Strong analytical skills to interpret complex data and make informed decisions.

    ·       High attention to detail.

    ·       Ability to identify issues, analyze root causes and propose effective solutions.

    ·       Ability to work collaboratively with other departments, such as operations, supply chain and others.

    LANGUAGE:

    ·       English (Bilingual Spanish preferred)

    SOFTWARE:

    ·       Office (Excel required), ERP Software (NetSuite or Adage / Assistics Preferred), QMS Software, (QPulse Preferred)

    * This salary range is an estimation made by beBee
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