Quality Engineer
Freudenberg Medical
Alajuela, Costa Rica
hace 5 días

You support our team as

Responsibilitiesarrow right

  • Ability to facilitate problem solving for defects that occur during manufacturing.
  • Provides expertise in manufacturing processes control for extrusion and injection molding components.
  • Audits and ensures manufacturing processes are in place to produce reliable products in a repeatable manner.
  • Conduct process audits and drive closure on improvement actions.
  • Coordinates development activities with Manufacturing and Engineering to help them in the process qualifications.
  • Coordinate all aspects of in-process inspections within cell(s), in-process inspections within cell(s), including training for long-term support of Six Sigma initiatives and compliance to ISO 13485, 14971, QSR, 21 CFR 820 and any other applicable standard or regulation.
  • Responsible for the Quality of all in-house manufactured parts.
  • Evaluate and determine disposition of non-conforming materials and formulate corrective actions.
  • Identify opportunities to improve manufacturing processes, e.g., lean techniques and optimized scale up.
  • Technical support of customers ensuring quality standards are understood, transferred appropriately and executed.
  • Internal coordination / liaison with engineering team to ensure appropriate control and introduction of any proposed changes to products and systems.
  • Provide process and quality support for manufacturing, validations, process improvement and productivity activities of new
  • Qualificationsarrow right

  • Deep Knowledge in Molding and Extrusion processes
  • 1-3 years related experience and / or training working knowledge of 21CFR820 (quality systems regulation / good manufacturing practices for medical devices), ISO 13485 and 14971 standards.
  • Requires excellent organizational, communications and project management skills and the ability to work effectively in a multi-task environment.
  • Projects manage tactical day to day activities along with higher level projects. Understanding and technical leadership and guidance with statistical techniques (i.

    e. sample size determination, DOE, Lean and Six Sigma process improvement techniques, etc.)

  • Knowledge and understanding of quality requirements for the medical device industry with general technical understanding of business operations.
  • Excellent verbal, written, analytical, computer and interpersonal skills with the ability to demonstrate lead capabilities with team approach, and sound decision making.
  • Organizational, prioritization, and presentation skills required.
  • Excellent interpersonal, communication, influencing, and facilitation skills.
  • Ability to work effectively cross functionally.
  • Bachelor's Degree in Engineering, or related science / technical field.
  • Physical Demands
  • Bilingual (English / Spanish) 90-100% desired.
  • Your Benefitsarrow right

    Health insurance

    Health insurance : Insurance : backstop protection against health risks

    Meal allowance

    Meal allowance : Allowance makes meals more affordable

    Diversity & Inclusion

    Diversity & Inclusion : Enter a diversity-driven world of innovation

    Training / Career development

    Training / Career development : Programs to supercharge skills and expertise

    Sustainability / Community service

    Sustainability / Community service : Making a difference with sustainability, community service Costa Rica : Local Candidates ONLY

    Submit Resume in English The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion.

    Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. autorenew

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