- Build productive and collaborative internal/external professional relationships across Design Divisions & GQO functions associated with design transfer activities.
- 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 performance and 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 product and process specifications and ensure these requirements have been met before product is released to market.
- Lead and ensure Risk Management documents are generated, applied to the process design and use instructions to minimize risk to patient or user harm. Ensure all Risk Management outputs comply with ISO14971 for use in Regulatory Submissions.
- Provide process validation support, and lead as required, both internally and with vendors. Technically understand the process in question, develop and provide input to process validation protocols, contribute to inspections/tests and analysis of the results.
- Has the authority to order the cessation of all activities in relation to design and 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.
- Support the development and implementation of inspection strategies and plans for associated NPI projects. Proficient in and makes continuous strides towards optimization of inspection methods and sampling. Leads / Support First Article Inspections.
- Minimize inspection costs while maintaining safety, integrity and reliability of the product.
- Support vendors during NPI phase in developing quality systems and resolving any quality issues in relation to audits findings, technical specifications, process validation, problem solving, sampling plans development and inspection techniques.
- 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.
- Provide process development support to ensure process characterization has been completed to facilitate subsequent validation activity.
- For new products, ensure the efficient and timely transfer of Quality systems knowledge to Ops Quality and coordinate the training of Quality Engineers and related personnel on new quality systems and equipment as necessary.
- Establish and report new products quality metrics and Monitor during Post-Market launch for prescribed period.
- Perform QMS Review and Approval of all process changes from a NPI perspective.
- Ensure all appropriate documentation is in place prior to production launch.
- Oversight and approval of NC & CAPA related to new products, activist and mentor in problem solving and root causing activities.
- Analysis and review of concession requests.
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
- Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
- Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality or technical discipline within an R&D or manufacturing environment
- Masters of Science, Engineering or related subject with 0 years of experience
- Previous experience in a regulated environment within an R&D or manufacturing environment.
- 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).
- Experience in executing complex problem-solving techniques related to design/technical issues. Good instincts and sound judgment for mechanical and structural design.
- Ability to manage several projects through the use of excellent analytical skills in planning, organising, and implementing multiple concurrent tasks.
- Excellent interpersonal skills – able to express ideas and collaborate effectively with multidisciplinary teams. Open minded- able to recognize good ideas.
- Strong team player who effectively utilises individual strengths and talents to maximise team services to customers. Focuses on achievement of team objectives and team success.
- Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
- Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
- Manages change well and adopts a continuous improvement orientation to the role
- Excellent English (both oral and written).
- Ability to be the voice of Quality when dealing cross functionally.
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!