Supplier Quality Engineer 2 (Alajuela, Costa Rica )

Life Unlimited. At Smith and Nephew, we design and manufacture technology that takes the limits off living

The Supplier Quality Engineer is primarily responsible for support and sustain of robust Supplier Management programs for designated manufacturing and development activities. Emphasis will be on component supplier, Contract Manufacturer and OEM activities that will assure that products meet design and process specifications consistently. The Supplier Quality Engineering will lead the implementation of data driven decisions and proven processes by utilizing engineering techniques and tools such as six sigma/DMAIC, statistics, predictive indicators, process validation, SPC, DOE, PFMEA, PPM defective, root cause analysis, etc. Deploy all critical to Quality (CTQ) control plans and measurement system analysis. In addition, the Supplier Quality Engineering will work with teams to develop the supplier risk mitigation strategy with procurement and category management.

This position is level P2* Only for internal Candidates

What will you be doing?

•   Lead the effort in Supplier Quality Engineering by working directly with suppliers to improve product quality and to mitigate, control and resolve supplier quality issues. Lead a Supplier Quality Engineering team to improve supplier performance and ensure reliable supply chain. Enlist support from internal company personnel and departments as needed. Utilize standard and advance statistical techniques to determine product acceptance, evaluate process capabilities, and develop statistically sound tolerance limits. Serve as a member or lead auditor of process auditing team and as lead auditor for existing supplier base as required. (

• Collects NCR, supplier corrective actions, deviations/concessions and related quality data for trending, scorecard maintenance and supplier performance reports to enable risk mitigation. Includes such activities as supplier assessment, supplier/product qualification and test method alignment. Provides key supplier performance metrics to the department manager, senior management and key stakeholders.

• Supplier Development and Improvement projects, including Supplier Change Notification process through the change control procedure. Develops and implements overall quality plan, including master validation plan, process map, quality control plan, inspection and testing techniques (Gage R&R), and Statistical Process Control (SPC) program. Assists with identification of needed biocompatibility and reliability testing, and procurement of inspection equipment and testing services. May also be asked to support process and product validation at suppliers and internal factories.

• Improves global and site Supplier Controls procedural requirements, e.g. as supplier qualification, supplier change notification supplier audit, supplier risk assessments, etc. as well as modifies existing drawings and specifications to improve quality and correcting errors. Initiates and approves engineering change requests if required.

• Supports customer complaints on supplier related issues by assisting in the analysis and the development of corrective action and proper documentation of complaint analysis.

What will you need to be successful?

Successful candidates would need the following:

• Education: Bachelor’s Degree in Technical Field (Engineering or Sciences) is required.

• Experience: +2 year of experience in SQE or Quality roles in medical device industry.

• ISO 9001 and/or 13485 Lead Auditor Certification (Required)

• USA VISA (Required)    

• Intermediate-High (B2) English level (Required)

• Competencies: Technical Knowledge  

• Basic knowledge of Project Management                                                 

• Intermediate Problem Solving (A3, DMAIC, 5 Why's, 8D, etc.)                 

• Knowledge on Process Qualification (IQ, OQ, PQ, TMVs)                    

• Intermediate knowledge on Microsoft Applications   

• Intermediate knowledge on Statistical Tools                                

• Regulatory and Notified Bodies Inspection Readiness                               

• Financial / Budgetary Tools                                                                    

• Limited knowledge of 2+ Mfg Processes (e.g., assembly, electro mechanical, injection molding, extrusion, sterilization, machining, etc.)         

• Limited knowledge Supplier Relationship Management (e.g., component, contract manufacturer, OEM, etc.)                                                            

• Business Expertise:                                                                                 

• Intermediate-High Product knowledge                                                   

• Business acumen                                                                                  

• Business operations knowledge                                                              

• Ability to escalate effectively                                                                  

• Stakeholder management                                                             

• Leadership Skills:                                                                                     

• Strategic Thinker                                                                                   

• Growth Mindset                                                                                     

• Ability to Motivate Others                                                                       

• Ability to communicate effectively at all Levels of Internal/External Organization         

• Effective Communication                                                              

• Problem Solving Skills:                                                                             

• Creative Thinker                                                                                    

• "I Own It" attitude                                                                    

•  Interpersonal Skills:                                                                                

• Decision Making                                                                                    

• Effective Communication                                                                

• Self-Motivated                                                                                 

• Personable                                                                                           

• Energetic                                                                                              

• Responsive                                                                                           

• Confident                                                                                             

• Honest and Passionate                                                                        

• Other:                                                                                                  

• Knows and adheres to the quality policy of the company and the quality related procedures and instructions.             

• Reports any deviation in product or process, of which he/she becomes aware, to his/her manager or the Quality departmen

• Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice).                             

• Immediately reports any dissatisfaction or complaint which is brought to their attention from a customer or patient regarding a Smith & Nephew product (e.g. in terms of quality, durability, reliability, safety or performance) to the complaints department.         

• Complies with all health, safety and environmental policies, procedures and job hazard analyses applicable to specified job activities, including medical evaluations as required by job function

• Completes all required HSE training.

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​​Physical Demands:        

• Weightlifting: Light (0kg - 10kg)                                               

• Position: 50/50 sitting / standing                                                        

• Repetitive Motion: Low:<10 moves/30sec                                             

• Chemical Exposure: No chemicals exposure or cleaning use only   

• Physical Risk (Personal Protective Equipment – PPE) may be required         

You. Unlimited

Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/

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…

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