Quality Engineer - NPI(NCS/Job/ 1879)

Analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. Apply quality principles, analyze quality records, prepare reports and recommend improvements. Conduct inspection, verification and validation of components or materials used in development processes. Identify and address recurring problems either with the quality of the product or the reliability of testing procedures. Document quality issues and performance measures for management review. May liaise with external vendors. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require an engineering degree in mechanical, and an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information.

This job typically requires a degree in mechanical engineering or equivalent and a minimum of 4 or more years’ experience.

· Job responsibility:

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

§ 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 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.

§ 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.

§ 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 capturing 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 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 process improvements, 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. Setup the inspection process at the site.

§ Minimize inspection costs while maintaining safety, integrity and reliability of the product.

§ Support supplier quality with vendors during NPI phase in developing quality systems at vendor / Stryker site 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 include the supplier part certification.

§ Support audit preparation strategy and execution. Participate in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.

§ 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 NPI process deliverables, including process changes.

§ 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.

§ Perform PPAP review and approval of all NPI Projects with Supplier