Quality Engineer

2 weeks ago

Indianapolis, United States Cork Medical Full time

Jumpstart your career at Cork Medical, a leader in negative pressure wound therapy solutions. Based in Indianapolis, Indiana our company's mission is to improve and positively impact the lives of the patients we serve, the partners we engage with, and the employees we invest in.

If you are looking for a rewarding opportunity where you can work alongside other dedicated individuals who will inspire you to grow your skills sets and advance your career, bring your passion and experience to Cork Medical

Job Summary:

The Quality Engineer will provide quality assurance support to the product development team, resolving bugs, defects, and other potential issues and ensuring that products meet customer specifications.

Duties/Responsibilities:

  • Develop, implement, and maintain quality systems that align with FDA regulations and other requirements.
  • Collaborate with cross-functional teams to identify areas for improvement in product quality and processes.
  • Analyze quality data to identify trends, root causes of defects, and opportunities for enhancement.
  • Prepare detailed reports on quality metrics and present findings to management.
  • Assist in the development of training programs related to quality assurance and control processes.
  • Ensure that all documentation related to quality management is accurate, complete, and up-to-date.
  • Audits all quality procedures and supporting documentation on a monthly basis to ensure all policies and procedures are followed.
  • Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of products.
  • Identifies root causes of problems in the production process; recommends and/or implements corrective measures.
Required Skills/Abilities:
  • Excellent verbal and written communication skills.
  • Excellent organizational skills and attention to detail.
  • Extensive knowledge of or the ability to quickly learn the organization's production processes.
  • Excellent interpersonal skills with ability to serve as a liaison with developers, project managers, and customer support.
  • Strong analytical and problem-solving skills.
  • Proficient with Microsoft Office Suite or related software.
Education and Experience:
  • Bachelor's degree in Engineering or a related field is preferred.
  • Proven experience in quality engineering or a similar role within a manufacturing or healthcare environment.
  • Familiarity with quality audits, ISO 13485 and FDA regulations are essential.
  • Strong analytical skills with the ability to interpret complex data sets effectively.
  • Excellent communication skills, both verbal and written, with the ability to work collaboratively in a team environment.
  • Knowledge of QA/QC methodologies and tools is highly desirable.
Physical Requirements:
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 15 pounds at times.

Join us as we strive for excellence in product quality and customer satisfaction

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