The Sr. Quality Engineer role is located in Coyol, Costa Rica supporting various product lines within the Smith + Nephew portfolio.
This position will support strategic design transfers. This role will support transfer activities within Operations Quality including but not limited to : process risk assessments (PFMEAs), process validations (IQ,OQ,PQ) and measurement system analysis.
This role will also support activities within Design Quality including but not limited to : design control elements (design verification / validation, user needs, etc.
and design change support. This individual must be experienced in design controls, risk management (DFMEA and PFMEA) as well as process validation.
This individual is expected to uphold compliance to regulatory requirements and Smith + Nephew Quality standards, policies, and procedures in all job aspects.
Support the transfer project team to develop Quality Plans to facilitate a compliant transfer from the sending site to the receiving site.
Work with the project team to establish timelines that consider all required project deliverables. (30%)
In accordance with the project objectives, ensure adequate gap assessments are performed and mitigated between sites with different Quality Management Systems. (30%)
Partner with the receiving site team(s) to establish robust process risk assessments as well as review / approve process validations to ensure stable and predictable manufacturing processes.
Support the design team(s) to complete the respective design controls deliverables and ensure design gaps between sending and receiving site are mitigated (30%)
Responsible for ensuring procedural adequacy through robust review and approval. Support document control and training activities to ensure timely and accurate processing of engineering change orders in compliance with internal procedures. (10%)
Location : Coyol, Costa Rica
Education : Bachelor’s degree in engineering or related discipline
Licenses / Certifications : ASQ CQE desirable, Six Sigma certification
Experience : 5+ years in the medical device or related industry.
Working knowledge of the following standards : ISO 13485 : 2016, ISO 14971 : 2019, IEC / ISO 62366 : 2015
Working knowledge in the following regulations : FDA 21CFR820, European MDD, European MDR
Proficiency in the following Software Applications : MS Office, MS Excel, MS Powerpoint, Minitab or other statistical software, SAP, and Agile PLM.
Experience working across multiple Quality Systems
Time management, ability to plan and schedule multiple projects and tasks
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.
Experience in : Process Validation, Design Controls, CAPA / NCR
Travel Requirements :