Quality Engineer II-1

Integer (Galway, Ireland) 4 days ago
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!

Position Summary:

The Quality Engineer will be expected to provide support to Operations, interact with customers and provide support for Engineering, Quality Systems and Process engineering.  Specializations may include but are not limited to: design control; material and process control; product reliability; software quality engineering; and/or metrology.

  • This position requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management, Corporate and other appropriate procedures for a variety of medical devices from concept through market introduction.
  • Maintain company compliance with Quality System Regulations and ISO 13485 standards.  Experience with FDA and ISO inspections and registration is a plus.
  • Actively participates in Internal audits, CAPA System, Document/Change Control, and other activities covered under Lake Region Medical Quality Manual, Policies and Procedures.
  • Provide customer-related quality and regulatory inquiries’ support.
  • Compiles and writes training material and conducts training sessions on QMS & Quality assurance activities.
  • Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner. Directs development and maintenance of internal/external standards relative to Design and Development,
  • Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, Capability Assessments, MSAs, CI and Process Validation.
  • Lead and provide Project Management support as needed.
  • Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
  • Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
  • Leads disposition of discrepant material and devises process to assess product quality and reliability.
  • Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration.
  • Manage and drive continuous improvement activities focusing on supplier quality.
  • Support supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA. 
  • Supports or may perform measuring, testing, and tabulating data concerning quality and reliability.
  • Acts as management representative in the absence of the lead quality engineer/manager.
  • All other duties as assigned.
  • Minimal travel may be required.

    Qualifications/Person Specification:

  • Bachelor degree in an Engineering/Science discipline.
  • 3-7 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility.
  • Experience with FDA and ISO 13485 Certification inspections is a plus.
  • Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred). 
  • Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include but are not limited to Statistics, SPC, Geometric Dimensioning & Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus.
  • Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.
  • Knowledge and experience of process validations would be advantageous
  • Proven to be self-directed, self-motivated and able to prioritize and resolve competing priorities.
  • Strong team member with the ability to identify and drive quality improvements.
  • Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills.
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