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.
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* Lead risk management activities and own quality engineering tasks for NPD projects.
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* Review design control compliance requirements for NPD projects and all design elements.
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* Perform statistical analysis to support product and process optimisation or resolve causes of process variation.
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* Initiate corrective actions as required.
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* 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.
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* A minimum of five years' experience in the medical device or pharmaceutical industries.
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* Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971, and CMDR.
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* Excellent problem-solving abilities, attention to detail, and adaptability.
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* 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.
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* A competitive salary and benefits package.
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* Ongoing training and development opportunities to help you grow in your career.
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* 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.