Senior Quality Assurance Specialist

6 days ago

Loch Garman, Loch Garman, Ireland beBeeQualityEngineer Full time €73,040 - €104,570

Job Overview

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The primary responsibility of this role is to ensure that new product designs and manufacturing processes meet all relevant safety and efficacy requirements.

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We are looking for a skilled professional who can manage multiple projects simultaneously, while collaborating effectively with cross-functional teams.

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Main Responsibilities

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  • Represent quality interests and concerns on project teams.">
  • Lead risk management activities and own quality engineering tasks for NPD projects.">
  • Review design control compliance requirements for NPD projects and all design elements.">
  • Perform statistical analysis to support product and process optimisation or resolve causes of process variation.">
  • Initiate corrective actions as required.">
  • Support assessment of biocompatibility testing required as per ISO 10993 and company procedures.">
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Requirements

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To be successful in this role, you will need:

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  • A third-level qualification in engineering, science, or a technical field.">
  • A minimum of five years' experience in the medical device or pharmaceutical industries.">
  • Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971, and CMDR.">
  • Excellent problem-solving abilities, attention to detail, and adaptability.">
  • Strong interpersonal skills, with the ability to work effectively in team environments and under your own initiative to target deadlines.">
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Benefits

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This role offers a range of benefits, including:

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  • The opportunity to work on challenging projects and make a real impact on the development of new products.">
  • A competitive salary and benefits package.">
  • Ongoing training and development opportunities to help you grow in your career.">
  • A dynamic and supportive working environment.">
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About Us

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We are an equal opportunities employer and welcome applications from diverse candidates. We are committed to creating an inclusive and respectful workplace culture.

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