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October 23 2018

    Job details


Job description:

   » Job ID.:15396097
   » Employer ID.:RI/R-319795
   » Published:12-OCT-2018
   » income:competitive
   » Job location:Enniscorthy, WEXFORD
   » Employment Type:PERMANENT


Quality Engineer II to back fill operations function on Project Polaris.

BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best in their professions. We are always seeking people who have a passion and commitment to join our Company on its journey in ‘advancing the world of health’.

At the Enniscorthy facility, ClearStream manufactures mainly angioplasty catheters that are used in both coronary and peripheral procedures to unblock arteries. We are now recruiting a Quality Engineer II (Operations).

As a Quality Engineer II (Operations), you will participate in day to day quality operations to ensure conforming materials are available for manufacturing. Works on problem solving and investigations to determine root cause of material non-conformances so that issues are resolved to close out with no recurrences.

Ensures compliance to quality system requirements as defined by ClearStream Technologies’ procedures, FDA QSR, ISO 13485 and applicable international and national standards (e.g. EN, ASTM) through active participation in the divisional and cross divisional product and process development system.

Key The main responsibilities are:
   » Performs timely disposition of non-conforming materials from: Incoming Quality Control or Manufacturing Processes, to ensure continued material compliance;
   » Supports development of appropriate product/component specifications and supports development and validation of inspection/test methods;
   » Supports pre-production QA activities and ensures information is adequately transferred during design transfer by interfacing with Operations, Engineering and Validation groups;
   » Applies risk management, change control, and validation principles all over the product lifecycle;
   » Supports the divisional corrective / preventive action program by applying root cause analysis and problem-solving techniques and by implementing corrective/preventive actions.

The prosperous candidate will have a Third Level Qualification and good expertise of design validation, design transfer and change control principles and techniques and expertise of pre-production QA principles and techniques (e.g. APQP, PPAP, MSA). Statistical methods and Six Sigma process excellence tools is a plus.

The ideal candidate will have practice in medical device industry or similar industrial environment with good working expertise of regulatory requirements and Quality Systems techniques. Shown to be a good team member and has practice of participating in team environment. You will lead cross-functional teams to develop risk assessments and risk controls.

You can look forward to a compensateing career, great benefits package, collaborative working and opportunities to expand your expertise in this fast moving, dynamic and agile business.

If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button.

This job originally appeared on


Job Category: Customer Service [ View All Customer Service Jobs ]
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Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Wexford
Company Type Employer
Post Date: 10/12/2018 / Viewed 3 times
Contact Information
Company: BD Medical

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