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Quality Systems Engineer

Company: Tecomet
Location: Warsaw
Posted on: March 18, 2023

Job Description:

Job Summary
The Quality Systems Engineer in this role ensures that corporate wide FDA QSR and EU MDR Training and Auditing programs are implemented and maintained. This position is also responsible for interfacing with the entire Tecomet organization to ensure the achievement of Tecomet regulatory objectives. This position will also be interfacing with and assisting the Electronic Quality Management System (eQMS) EtQ Reliance Systems Administrator(s) when needed for module implementation, training or managing questions. He/she must have or develop a good working knowledge of EtQ Reliance. This is a hybrid role.
This role will be responsible for developing and implementing a corporate wide audit program including Internal and Cross-Functional Audits to assess Tecomet site compliance with both Agency Regulations and Tecomet requirements.
This will be accomplished within Tecomet's principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.
Essential Duties and Responsibilities

  • Develop employee training curriculum(s) based on Compliance and Tecomet needs;

  • Implement and assist in all aspects of corporate wide training activities including coordination, performing training, etc.;

  • Implement and maintain a compliant Audit program;

  • Identify gaps in Audit expertise, identify site resources for audit training and manage the training plan;

  • Perform Cross-Functional Audits and coordinate corrective action as needed;

  • Support Tecomet wide FDA Inspections and/or Notified Body Audits;

  • Adjust and prioritize work to meet deadlines while maintaining quality standards;

  • Conduct training on topics such as QSR's, Audit behavior or site specific subjects;

  • Lead individual or group training initiatives for EtQ module implementation;

  • Assist the EtQ Reliance Systems Administrator(s), perform training or manage questions as needed.

  • Have or develop a good working knowledge of EtQ Reliance.

  • Ability to track and trend Quality Systems data to provide feedback to Managers and QARA Leaders on the health of the Quality Management System.

  • Performs other duties or special projects as required or as assigned by manager.

    Qualification Requirements

    • Bachelor's Degree in Engineering or related field, & Certification (ASQ CQE, CQA or other 3rd Party Auditor Certification) is preferred with 4 years' experience;

    • OR a combination of an Associate's Degree in Engineering or related/equivalent field with Certification (ASQ CQE, CQA or other 3rd Party Auditor Certification) and at least 6 years' experience in a quality role within the Medical Device Industry;

    • OR without a degree, a minimum of 8 years' experience within the Medical Device Industry, and Certification (ASQ CQE, CQA or other 3rd Party Auditor Certification)

      Knowledge, Skills, and Abilities

      • PC Literacy, Knowledgeable with MS Office tools such as Word, Excel and PowerPoint

      • Able to prioritize and manage multiple tasks simultaneously and complete within required timeline.

      • Good working knowledge of project management tools & principles;

      • Excellent communication and interpersonal skills

      • Ability to work independently and exercise judgment

      • Self Management/Decision making capability;

      • Problem solving;

      • Self-motivated;

      • Positive attitude/high energy level.

        Other Requirements
        Mental Requirements:
        The work environment is representative and typical of similar jobs in comparable organizations.
        Travel Requirements:
        This position will require domestic and international travel, possibly as high as 50%. However, travel schedules will be coordinated with other team members to minimize extended travel.
        Physical Requirements:
        While performing the duties of this job, the employee could be required to stand. The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.
        Americans with Disabilities Act (ADA):
        Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
        The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.

Keywords: Tecomet, South Bend , Quality Systems Engineer, Other , Warsaw, Indiana

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