Quality Engineer 2 Temp 1 año
Alajuela, Coyol, CR
hace 4 días

Role Overview :

This position will implement the quality activities necessary to move a product line from internal manufacturing to a contract manufacturer and merge the requirements necessary as a legal manufacturer of the product into an existing quality system.

This involves quality system updates, procedure generation, training, and technical support. The Quality Engineer determines methods, techniques, and evaluation criteria for medical devices.

He / she serves as a key resource for ISO, US FDA, and QSR requirements.

Responsibilities :

40%) Plan and implement the updates necessary to ensure the Quality System of the new legal manufacturer meets all requirements associated with a combination production (medical device and drug).

Ensure compliance to product specific standards, QSR, US FDA, ISO, IEC, and UL requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.

35%) Provide quality leadership to project teams as the quality engineering representative. Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications / standards and that the safety and reliability of products are established.

Generate / approve / manage sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.

10%) Support establishing contract manufacturer operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.

10%) Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier.

5%) Support Management Review and audits / inspections.

Education Requirements :

  • Bachelor’s degree in engineering or life science discipline
  • Licenses / Certifications :

    Minimum Experience :

  • 2-5 years in the medical device or regulated industry
  • Other Requirements

  • English level B2+ or higher is mandatory.
  • Competencies :

  • Need to be able to make sound decisions with attention to details
  • Understanding the impact of regulatory requirements (e.g. GMP’s, ISO 13485, and ISO 14971) on Smith & Nephew’s products is necessary
  • Must be able to provide and implement solutions to quality problems
  • Ability to plan and schedule multiple projects and tasks
  • Effective written / oral communication skills
  • Team player
  • MS Office, MS Excel, and Statistical software proficiency
  • Physical Demands :

  • Weight Lifting : Light (0kg - 5kg)
  • Position : Mostly sitting
  • Repetitive Motion : Mostly computer use
  • Chemical Exposure : No chemicals exposure or cleaning use only
  • Physical Risk (Personal Protective Equipment PPE) : Occasional use of PPE required
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