Quality Engineer II

Galway  ‐ Onsite
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Description

The Quality Engineer job is based in Galway on a Permanent basis. This job is with one of the most recognised Medical Device Company's in the world and offers huge opportunities for learning and growth.

About the Employer:

This Company are a leading innovator of medical solutions that improve the health of patients around the world. Their products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women's health, and chronic pain conditions.

About the Job:

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Responsibilities
  • Identifies and resolves complex exceptions to work assignments.
  • Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
  • Participates in Customer Complaints investigation for areas under their control.
  • Continually seeks to drive improvements in product and process quality.
  • Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
  • Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
  • Knowledgeable on Risk Management, BSEN 14971 requirements.
  • Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
  • May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
  • Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
  • Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
  • Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives?
  • Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
  • Is familiar with the internal auditing process.


Qualifications and Experience:
  • HETAC Level 8 qualification in a relevant area with a min. of 3-4 years relevant experience.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Proven ability to work well both as part of a team but also able to work on own with minimum supervision.


Benefits:

- Competitive Salary

- Great bonus -Full Healthcare - Pension

To Apply:

Aaron O'Byrne /

Please see www.realstaffing.com for all exciting Quality Engineering jobs in the pharmaceutical/medical

Click Apply in order to send your CV on for this position. If you do not have an up to date CV do not hesitate to contact me directly on the below number for a chat.
Start date
03/2016
From
Real Staffing
Published at
15.04.2016
Project ID:
1111193
Contract type
Permanent
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