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Integer Associate QS Engineer in Galway, Ireland

At Integer, our vision and values are embedded in everything we do!

If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!

JOB SUMMARY

The Quality Systems Engineer will primarily be responsible for coordinating, maintaining and improving where necessary all product and process quality systems in Integer Galway.

Accountabilities include:

  • Ensure continued compliance with all Regulatory Standards. This includes:

  • ISO 13485

  • FDA QSR

  • Ensuring continued compliance with DMR

  • Co-ordination of the Complaint program and compilation of Complaint metrics.

  • Co-ordination of the CAPA program and compilation of CAPA metrics.

  • Act as SME (subject matter expert) with respect to internal audit, complaint handling, CAPA handling and the eQMS.

  • Takes a leadership role in developing and implementing new techniques and initiatives to enhance the QMS

  • Generation of ECO’s and change control documentation as required.

  • Management of the supporting elements of the Quality Management system.

  • Co-ordinate the internal audit program. Publishing schedules, coordinating with auditors. Generate metrics.

  • Co-ordinate the CRA program with stakeholders. Generate metrics and publish progress.

  • Participates in external regulatory audits

  • Compile weekly/monthly Quality Reports.

  • Perform Quality Systems Trending by compiling; weekly/monthly quality reports, raw data for Quality KPIs and trending for Operations Reviews and Management Reviews

  • Playing a role in the plant annual objectives.

  • Ensure the company behavioral standards are adhered to, setting the example yourself for your direct reports.

  • Project meeting attendance as required.

  • Ensure that in your absence your department provides adequate day to day service. Ensure that other departments know of your arrangements well in advance.

  • Ensuring backup and notification for any absences within the group, and being able to step down when required based on priorities.

  • Work efficiently using own initiative, escalating decisions to the QS / RA Supervisor as necessary.

SKILLS AND KNOWLEDGE:

  • Ability to communicate and work with people inside and outside the department.

  • Good communicator (written and oral).

  • Ability to train and lead.

  • Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance

  • Good presentation skills to conduct training and presentations

  • Knowledge of engineering theories and methods.

  • Knowledge of Document Control.

  • Good technical report writing skills.

  • Rigorous attention to detail.

  • Knowledge of eQMS modules / processes such as Complaints, CAPA etc. MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

  • Engineering or Science Degree

Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .

Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at

716-759-5739.

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