Título del trabajo: Design Quality Engineer I (Coyol, Alajuela)

Compañía: Smith & Nephew

Descripción de funciones: Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.Are you interested in making a global impact? This position will support sustaining activities for launched Joint Repair products, such as design change support, product issue support, and Post Market Surveillance data review. They will lead root cause investigations, review Design Verification and Validation documents, and support audits.Job level (for internal use only): P1What will you be doing?

  • Support sustaining projects (Quality Plans, remediation activities, etc.). Work with a team to develop methods and procedures, ensuring the appropriate tests are conducted to ensure that products meet the required specifications/standards and that the safety and reliability of products are established. Generate/approve/handle design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.
  • Support compliance and complaint management processes (CAPA’s, NCR’s, Post Market Surveillance activities, Management Review, Risk Management Review, Complaints Investigations). Serve as a quality engineering resource to conduct/approve investigations.
  • Identify/Support continuous improvement activities. Engage with multi-functional resources to receive product feedback.
  • Support internal/external audits, when vital.

What will you need to be successful?

  • Education: Degree in engineering or related field.
  • Experience: Experience working across multiple Quality Systems Time management, and the ability to plan and schedule various projects and tasks, is a plus.
  • Experience in CAPA, NCR systems including problem identification, root cause investigation, corrective action/preventative action definition and implementation.
  • Languages: Advanced English level.
  • Competencies: Proven understanding of the following standards: ISO 13485:2016, ISO 14971:2019, IEC/ISO 62366:2015.
  • Working knowledge in the FDA 21CFR820, European MDD and European MDR regulations.
  • Proficiency in the following Software Applications: MS Office, MS Excel, MS PowerPoint, Minitab or other statistical software, SAP, and Agile PLM.
  • Understanding of statistical tools, including, but not limited to: Bayes Success-Run, Weibull Analysis, t-tests, tolerance analysis, capability analysis, design of experiments/ANOVA, etc.

You. UnlimitedWe believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about on our website.Other reasons why you will love it here!

  • Your future: stock purchase program, referral bonus, subsidy in transport and food, recognition program.
  • Work/Life Balance: Extra days off, birthday off, voluntary hours.
  • Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave.
  • Flexibility: Hybrid work model (for more professional roles), flexible schedules.
  • Training: Training program, unlimited learning.
  • Extra perks: employees association, and more…

#LI-HYBRIDStay connected and receive alerts for jobs like this by joining our .We’re more than just a company – we’re a community! Follow us on to see how we support and empower our employees and patients every day.Check our for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our and learn more about our mission, our team, and the opportunities we offer.

Ubicación: Alajuela

Fecha del trabajo: Fri, 28 Jun 2024 23:04:46 GMT