Sr. Supplier Quality Engineer
Smith & Nephew
El Coyol, Provincia de Alajuela, San José, Costa Rica
hace 4 días

ESSENTIAL FUNCTIONS

Lead the effort in Supply Chain Management by working directly with suppliers to improve product quality and to mitigate, control and resolve supplier quality issues.

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 NCMR, 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 Supplier Change Process through the process change management 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.

Can be asked to support process and product validation at suppliers and internal factories.

Improves SOP's, such as supplier qualification, supplier change notification and incoming inspection documents, 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 supply chain related issues by assisting in the analysis and the development of corrective action and proper documentation of complaint analysis.

Education :

Bachelor’s Degree in Technical Field (Engineering or Sciences) is required. Master’s Degree in Technical Field (Engineering or Scientific) is preferred .

Licenses / Certifications :

  • ISO Lead Auditor Certification (Preferred).
  • American Society of Quality (ASQ) Certified Quality Engineer (CQE) is preferred.
  • Green or Black Belt is preferred.
  • Experience :

  • 5-7 years of Technical (Engineering or Sciences) or transferrable experience is required. Medical device is preferred.
  • Experience implementing lean manufacturing and / or six sigma techniques towards problem solving, Experience with Quality System Requirements (QSR), ISO 13485 & 14971
  • Supervision : None required for this position.
  • Competencies :

    Project Management Skills, Statistical Analysis, Validation, Structured Problem Solving Process (A3, DMAIC, 5 Why's, 8D, etc.

    Decision Making, Exercising Influence, Ability to Influence at all Levels of Internal / External Organization, Communication, Facilitation, Self-

    Motivated, Ability to Motivate Others, 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 department
  • 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
  • Weight Lifting : Light (0kg - 5kg)
  • Position : 50 / 50 sitting / standing
  • Repetitive Motion : Low :
  • Chemical Exposure : No chemicals exposure or cleaning use only
  • Physical Risk (Personal Protective Equipment PPE) : No PPE required
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