Senior Quality Engineer, NPI in Carrigtohill at Stryker Corporation

Date Posted: 2/14/2020

Job Snapshot

Job Description

Provide quality engineering support and direction in quality assurance, control and preventative activities in the development and introduction of new Products, Processes and Technologies, with focus on quality systems development, risk management, test & inspection strategies and product reliability. Advocates and leads the execution of quality activities in product development, verification, validation, design transfer and post market release phases whilst ensuring compliance to regulation and standards.

Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

  • 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.

Work From Home: Not available

Travel Percentage: None

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