Sr. Quality Engineer - New Product Development Process Quality
Stryker
Gurugram, IN
2d ago

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products.

As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better.

Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products.

You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team : https : / / www.strykercareersblog.

com / post / 8-reasons-to-join-strykers-engineering-team

Who We Want

  • Dedicated achievers . People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Analytical problem solvers . People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevents future issue
  • Collaborative partners . People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
  • What You Will Do

  • 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
  • What You Will Do

    Professional Requirements

  • B.Tech (Electronics / Electrical / Mechanical) with more than 8 years of experience in Quality / Engineering / Manufacturing environment.
  • Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.)
  • Technical Competencies

  • Quality Processes / Tools - Working knowledge of basic and advanced Quality tools such as; Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc.
  • Executes / Masters & implements / improve all supplier quality tools / Processes . Trains supplier in these tools effectively.
  • Commodity Domain Knowledge Strong Knowledge & understands technology, regulatory requirement related to product, system & services.
  • Determine supplier technical abilities based on these knowledges.

  • Knowledge of Simulation based / Paperless Validation Tools : - Working knowledge of Paperless Validation Tools such as Val Genesis for verification of laser etching artworks.
  • Proficiency in prioritizing, reviewing, and performing First Article Inspections FAIs for sustaining parts and development projects
  • Working knowledge of Process Validation and Computer System validation
  • CQE or equivalent course work / experience is desirable
  • Familiarity with ISO 13485, QSR, GDP, GMP desirable.
  • Basic understanding of Medical Device Regulatory Compliance ( EU MDR Regulation (EU) 2017 / 745 ) and EU's Medical Device Directive ( MDD - 93 / 42 / EEC )
  • Fact based analysis

  • Structurally collects facts to base his / her opinions on and ensures data integrity and traceability of data is flawless
  • Based on deep analysis of the facts, comes to conclusions and decisions that are undisputable and strongly supported by the facts
  • Uses and continuously improves processes based on deep understanding of their background to achieve excellent results
  • Know someone at Stryker?

    Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https : / / careers.

    stryker.com / referrals /

    About Stryker

    Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

    We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

    We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

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