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Quality Systems Manager at Ametek, Inc. in Mount Prospect, Illinois

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

This Quality Systems (QS) Manager is responsible for managing the ongoing development, implementation, and maintenance of the Quality System at Rauland. The QS Manager will ensure the implementation of an effective Quality Management System (QMS) that complies with applicable regulations (i.e., 21 CFR 820; ISO-13485:2016; ISO- 14971, etc.) and standards, including the elements of design controls, risk management, document control, internal auditing, external audits (i.e., FDA, ISO Registrar, UL), complaint management, Corrective Action/Preventive Action (CAPA), quality performance reporting, training, Field Corrective Action (FCA) Management, site registrations and management reviews. The Quality Systems Manager has proven leadership skills in managing a staff and in working collaboratively across multiple functions. The QS Manager is also experienced in multiple areas of medical device quality assurance and is capable of applying that experience and in-depth knowledge to proactively drive continuous improvement initiatives and work independently with minimal guidance from management. Serves as a technical reference and subject matter expert for colleagues with less experience. This position will provide leadership for improvement projects and will have the ability to solve problems affecting the quality system.

Major Responsibilities:

  • Responsible for providing governance and oversight of the QMS and the elements of the site quality system including:

    • Internal & External Audits
    • Corrective & Preventive Action (CAPA)
    • Risk Assessments
    • Document Control & Record Management
    • Quality Agreements
    • Training
    • Customer Complaints
    • Management Reviews
    • Validation
    • Non-Conformances
    • Design Controls
    • FCA Management
  • Maintain and improve the Quality Management System (QMS) to comply with all applicable requirements for medical devices (i.e. 21 CFR 820 Quality System Regulation; ISO 13485:2016; ISO 14971:2019).
  • Utilize knowledge and expertise to identify, solve and document problems and risks within the quality system.
  • Provide leadership for improvement projects and support development of quality objectives.
  • Conduct and support training (i.e., QSR, GMP's, Internal Auditing, FDA Inspections, Quality Reporting, Customer Complaint Management, Document Control, etc.).
  • Serve as a Subject Matter Expert (SME) for colleagues.
  • Manage the Internal Audit Program via the annual schedule and support External Audits (i.e. FDA, UL, etc.)
  • Facilitate Quality Management Reviews to assess the health of the QMS and drive continuous improvement.
  • Lead a team of subject matter experts for the various standards, regulations, and quality management systems processes to assure consistent and high-quality execution.
  • Lead the CAPA Review Board (CRB) and drive successful CAPA closure.
  • Maintain the Quality Manual and site registrations and certifications.
  • Manage complaints and FCA activity including recalls.
  • Ensure the QMS electronic platform is managed effectively, and updates are integrated successfully.
  • Oversee risk assessments as required to assist in making process and product related decisions.
  • Manage direct reports and be accountable to execute on the Ametek/Rauland talent strategy. Evaluate team member potential, drive succession planning, and provide required coaching to develop individual and team capability.
  • Promote a team environment of engagement, diversity, equality, and inclusion.
  • Contribute to the creation and progress of the Rauland Quality & Regulatory Affairs Strategic Plan.
  • Support data collection, quality report preparation and metric creation/deployment.
  • Champions the Rauland Quality Policy and the tenets of Customer Satisfaction, Regulatory Compliance, Continuous Improvement and Team Engagement.
  • Education & Experience:


    • Bachelor's Degree in Science or technical field and 8+ years of experience in the Medical Device Industry.
    • Strong experience working with a Quality Management System (i.e., Master Control Platform; Qumas Platform, etc.) and its elements.
    • Experience managing a staff of quality system/assurance professionals.
    • Solid experience working in a Class I and Class II Medical Device environment.
    • Extensive knowledge of medical device regulations/standards including 21 CFR 820 (QSR) and ISO - 13485:2016.
    • Knowledge of ISO 14971:2019 (Risk Management for Medical Devices).
    • Experience in Design Controls and conducting training courses.
    • Experience hosting and supporting external audits (i.e., FDA Audits, Customer Audits, Corporate Audits, UL, etc.).
    • Certifications preferred - i.e., Internal Quality Auditor, Quality Systems/Management, Risk Management.
    • Knowledge of Lean/Six Sigma process improvement approaches and techniques.

    Compensation

    Salary Minimum: Market

    Salary Maximum: Market

    Incentive: No

    Disclaimer: Where a specific pay range is noted, it is a good faith estimate at the time of this posting. The actual salary offered will be based on experience, skills, qualifications, market / business considerations, and geographic location.

    AMETEK is committed to making a safer, sustainable, and more productive world a reality. We use differentiated technology solutions to solve our customers' most complex challenges. We employ 18,500 colleagues, in 30 countries, that are grounded by our core values: Ethics and Integrity, Respect for the Individual, Diversity and Inclusion, Teamwork, and Social Responsibility. AMETEK is a leading global provider of industrial technology solutions serving a diverse set of attractive niche markets with annual sales of over $6.0 billion. Traded publicly (NYSE:AME), we are a component of the S&P 500. Visit www.ametek.com for more information.

    We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1 (866) 263-8359.

    Nearest Major Market: Chicago





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