Engineer II, Quality - CR (Shift C)

Support the development and manufacturing of existing and new introduction of medical devices. Work with Manufacturing and R&D to resolve product quality issues, which may include field complaints. Support manufacturing process changes, product design improvements, and the implementation of new products. Job duties:

• Work with manufacturing engineers to review process changes, resolve product quality issues, and assess related risks.
• Work with suppliers to maintain high quality levels of incoming production materials.
• Participate in quality audits of suppliers, if required.
• Work with R&D engineers to support implementation of new products by reviewing quality and testing plans.
• Work with R&D manufacturing engineers to develop the FMEAs, as required.
• Works with R&D and manufacturing engineers to develop test protocols and reports (e.g., design verification, design validation, process qualification, and process validation) and review their proper execution.
• As assigned, maintain various Quality Systems such as CAPA, Non-Conformance (NCR), Supplier Quality, equipment calibration, internal auditing, and quality metrics data analysis.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Job Details

Job ID 14801BR

Alajuela, Costa Rica

• Qualifications

  • Bachelor’s degree in engineering or a related field.
  • Minimum of three (3) years of related medical device manufacturing experience.
  • Intermediate computer skills and knowledge of MS Office package, including Word, Excel, Power Point, Teams and Outlook.
  • English level B1or above (based upon Belt Certification Process).
  • Ability to read and interpret PFMEA Risk assessment tool to defined further actions determination.
  • Minimum one (1) year of root cause analysis experience (related certification desired but not mandatory, including Fishbone).
  • Ability to read, interpret and execute validation processes for the medical industry, including TMs / VQPs & VQRs.
  • Ability to read and interpret production and process controls for the medical industry (e.g., Acceptance Activities, risk control measures).
  • Minimum one (1) year of firsthand experience with Nonconforming product handling and evaluation for the medical industry and further action determination.
  • Effective and strong written and verbal communication skills; ability to partner with associates at various levels within the organization.

  Desired Qualifications

  • Basic knowledge of ISO 13485: Understanding of the ISO 13485 standard for medical device quality management systems (certification is preferred but not required).
  • Familiar with medical device quality systems: General understanding of quality system regulations and quality assurance methodologies applicable to the medical device industry.
  • Basic knowledge of company products and processes: Awareness of the company’s product portfolio and associated manufacturing processes.
  • Proficiency with statistical software (Minitab, Stratigraphic, Design of Experiment DOE).
  • Basic understanding of complaint handling process: Basic knowledge of complaint management processes and regulatory expectations within the medical device sector.
  • Basic understanding of Nonconforming product handling process: Basic knowledge of Nonconforming product management processes and regulatory expectations within the medical device sector.
  • Basic knowledge of risk management principles, practices, and standards relevant to the medical device industry (e.g., ISO 14971).