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

Are you ready to take the next step in your career? The Supplier Quality Engineer II is primarily responsible for support and sustaining 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. This person 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.

This position is a P2 level 

What will you be doing? 

Work directly with suppliers to improve product quality and to mitigate, control and resolve supplier quality issues.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.Supports Network Optimization and 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.Deploy all critical to Quality (CTQ) control plans and measurement system analysis. In addition, Supplier Quality Engineering will work with teams to develop the supplier risk mitigation strategy with procurement and category management.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?  

Required Qualifications

Experience: +2 years of experience in SQE or Quality roles in medical device industry.Languages: Advanced English skills.Education: Bachelor’s Degree in Technical Field (Engineering or Sciences).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 (Excel, Power Point, Word)
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.)

Preferred Qualifications

Certifications: ISO 9001 and/or 13485 Lead Auditor

Competences: 

Business acumenAbility to escalate effectivelyStakeholder managementStrategic ThinkerGrowth MindsetAbility to communicate effectively at all Levels of Internal/External OrganizationDecision MakingEffective CommunicationSelf-MotivatedPersonableEnergeticResponsiveConfidentHonest and Passionate

You. Unlimited 

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.  

Inclusion+belonging: Committed to Welcoming, Celebrating and Thriving, learn more about employee inclusion groups 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.  Training: Training program, unlimited learning. Extra perks: employees association, and more… 

#LI-ONSITE

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