Snr Quality Engineer, NPI in Carrigtohill at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Carrigtohill
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/25/2018
  • Job ID:
    30431BR

Job Description

Your key responsibilities:

  • Build productive and collaborative internal/external professional relationships across Design Divisions & GQO functions associated with AO activity
  • Communicate effectively with all Customers, Stakeholders and project teams in delivering on AQE functional responsibilities
  • Promote AQE capabilities to 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.
  • Co-ordinate AQE input to the development and maintenance of a process that ensures that customer and regulatory requirements are incorporated into product specifications and ensure these requirements have been met before product is released to market
  • Lead the development of internal Quality Systems to facilitate interdivisional NPI activity.
  • In partnership, develop Supplier Quality Systems related to NPI and ensure Suppliers’ ability to deliver new products and components right first time.
  • Develop & Implement Risk Management Principles in compliance to ISO13497 for product design, process design and use instructions to minimize risk to patient or user harm. Co-ordinate Risk/benefit justification of the product for its intended use.
  • 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.
  • Co-ordinate AQE input to the development of process validation activities for the AO function. Embed Validation Certification programme within AO function.
  • Co-ordinate AQE input to the development of incoming inspection, in-process inspection procedures and final inspection plans as it applies to NPI projects. Focus on minimising inspection costs while maintaining safety, integrity and reliability of the product.     
  • Collaborate with Stakeholders on AQEs supporting Vendors during NPI phase in resolving quality issues in relation to audits findings, technical specifications, process validation, problem solving, sampling plans development and inspection techniques.
  • Collaborate with Analytics function in overseeing  AQE application of appropriate statistical techniques (Six Sigma, Anova, DOE, SPC, Gauge R&R etc.) to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
  • Act as a Subject Matter Expert in Design Control for the AQE function and represent them in Audit situations.                                                                                                                                    
  • Devise and manage audit preparation strategy and represent AO function in Audit situations both third party external (Including Corporate, FDA, BSI & TGA) and internal Quality Audits.
  • Mentor graduates in AQE role  as appropriate
  • Lead M&A projects from an AQE perspective
  • Lead and plan Design Transfer file activities from initiation to close out as Subject Matter Expert in NPI Design Transfer for the project team. 
  • Provide process development support to ensure process characterization has been completed to facilitate subsequent validation activity.
  • For new products, support the development and management of a process that ensures 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
  • Co-ordinate the monitoring and reporting of new products quality metrics to the company’s leadership team during Post-Market launch for prescribed period.
  • Co-ordinate and perform QMS Review and Approval of all Process changes affecting Stryker IRL sites from a NPI perspective
  • Ensure all appropriate documentation is in place prior to production launches


What we are looking for:

  • Bachelor's Degree in Science, Engineering, Quality or equivalent discipline is required
  • A minimum of 4 years’ experience in a technical position within an R&D or manufacturing environment or equivalent
  • A minimum of three years’ experience as an AQE is a distinct advantage.
  • Working Knowledge of Process Validation and Computer System validation
  • Excellent communication, organisation and time management skills  
  • Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment.
  • Experience in delivering within a Mergers & Acquisition  initiative or multi-site technical improvement programme is a distinct advantage
  • Demonstrated  knowledgeable and work experience of FDA Quality System Regulations and / or ISO 13485 with Frontroom experience
  • Expert in reading and interpreting complex engineering drawings and having a good understanding of geometrical dimensioning and tolerance.
  • Strong Anatomical awareness knowledge
  • Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.  Open minded- able to recognize good ideas.
  • Innovative thinker - able to envision new and better approaches to meet business needs
  • Must be able to analyse and correct complex product and/or process issues and make decisions using independent judgement
  • Strong knowledge in MSA for  Inspection Planning & Implementation
  • Strong knowledge in GD&T methodology
  • Experience in applying Design Risk Analysis & Controls to New Product Introductions   
  • Working knowledge of basic statistical techniques (Minitab - basic level or equivalent)       
  • Ability to lead and train lower level employees.
  • Ability to build strong customer engagement and credibility by delivering on expectations and commitments.  
  • Experience in generating, following and explaining detailed operating procedures    (i.e. assembly instructions, inspection procedures etc.).
  • Knowledge of products/processes associated with relevant division(s)
  • Must be able to work with minimal supervision.                                                                                                                                                                            

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Work From Home: No

Travel Percentage: None

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