Our client, a medical device company in Cork is currently looking to recruit a Staff Quality Engineer NPI for their site.
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities
- Initiate and build productive and collaborative internal/external professional relationships across Design Divisions & GQO functions associated with design transfer activities. Encourage, inspire, and influence others, creating a positive impact on the team.
- Communicate effectively with all Customers, Stakeholders and project teams in delivering on quality, transfer and NPI project goals.
- As a key member of NPI project teams, be accountable for implementing quality systems while achieving product/process performance, quality objectives, project planning and effective execution, as well as communicating program status and escalating issues when appropriate.
- Ensure that customer and regulatory requirements are incorporated into y process specifications and ensure these requirements have been met before product is released to market.
- Experienced in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
- Develop & Implement Risk Management Principles. Lead and ensure Risk Management documents are generated, applied to the process to minimize risk to patient or user harm. Ensure all Risk Management outputs comply with ISO14971 for use in Regulatory Submissions.
- Support process development, process characterization and capture process knowledge to facilitate subsequent process validation and monitoring activities ensuring ongoing product compliance.
- Has the authority to order the cessation of all activities in relation to process validation and new product introduction. In addition, has the authority to order recommencement of these activities provided he/she is satisfied that all issues affecting product safety and efficacy have been addressed. Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
- Lead the development and implementation of process improvements, inspection strategies and plans for associated NPI projects. Takes initiative in and makes continuous strides towards optimization of inspection methods and sampling. Leads / Support First Article Inspections.
- Optimise inspection costs while maintaining safety, integrity and reliability of the product.
- In partnership, develop Supplier Quality Systems related to NPI and ensure Suppliers’ ability to deliver new products and components right first time.
- High proficiency in statistical methods and application. Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
- Subject Matter Expert in Design Transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise. Support audit preparation strategy and execution.
- Lead and plan Design Transfer file activities from initiation to close out.
- Responsible for and ensures the efficient and timely transfer of knowledge to Quality engineering support of the production environment. Coordinate the training of Quality Engineers and related personnel on new quality systems, processes and equipment as necessary.
- Oversight and activist of NC & CAPA related to new products, expert and mentor in problem solving and root causing activities.
- Co-ordinate the monitoring and reporting of new products quality metrics to the company’s leadership team during Post-Market launch for prescribed period.
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
- Support due diligence and associated activities during mergers and acquisitions.
- Mentor to support groups and other functions on areas of expertise pertaining to design and process transfer, risk, statistics, validation and problem solving.
The Ideal candidate:
- Engineering/Science licence and 5 or more years work experience in a quality or technical discipline or Bachelor of Science, Engineering or related subject with 4 years’ experience in a quality or technical discipline
- Masters of Science, Engineering or related subject with 2 years of experience in a quality or technical discipline
- Previous experience in a regulated environment within an R&D or manufacturing environment required. 2 years’ experience in new product/process is a distinct advantage.
- CQE or equivalent course work / experience desirable
- Proficient in understanding of Med Device manufacturing processes desirable.
- Familiarity with ISO 13485, QSR, GDP, GMP desirable.
- Lean Six Sigma training a distinct advantage.
- Working knowledge of Process Validation and Computer System validation
- Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment.
- Ability to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerance.
- Must be able to generate, follow and explain detailed operating procedures (i.e. assembly instructions, inspection procedures etc).
For further information on this Staff Quality Engineer role please contact Orla on 0860449473 / firstname.lastname@example.org
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