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Senior Quality Assurance Engineer
4 weeks ago
Senior Quality Assurance Engineer Role & Responsibilities Support sustaining commercial projects from a Design Assurance perspective.
You will be directly involved in making sure our products are maintained through the full product lifecycle and that these products comply with global standards.Support the introduction/implementation of product/process/materials changes to the manufacturing operation.
You will assess the patient risk appropriately for these design changes.
You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg.
Engineering.Responsible for generation of Design Verification protocols & will participate in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment.As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities.
You will generate and approve change requests.
Lead investigation analysis and timely completion of same.Collaborates with engineering and manufacturing functions to ensure quality standards are in place.Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specificationsEnsures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.Collaborate with complaints team for complex investigations.Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
Requirements Requires a Bachelor's degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.Strong problem solving and analytical skills Strong problem-solving skills with the ability to identify root causes and implement corrective actions.Strong technical writing ability.Applying Statistical Analysis Design Verification Dynamic team player who can work effectively and proactively on cross-functional teams Good communicator and fluent in English, both in writing and speaking.
Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures
Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.
For further information on this role please contact Geraldine Gormally on 0861071395/****** Check out all our open jobs on our HERO Recruitment website – Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
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