Danaher - Coralville, IA

posted 4 months ago

Part-time - Mid Level
Hybrid - Coralville, IA
1-10 employees
Computer and Electronic Product Manufacturing

About the position

Integrated DNA Technologies (IDT) is seeking a dedicated Quality Engineer to join our Regulatory Affairs and Compliance Department in Coralville, IA. This hybrid position offers the opportunity to work part-time at our company location and part-time remotely. As a leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications, IDT is committed to maintaining high-quality standards and ensuring customer satisfaction. In this role, you will be instrumental in driving root cause investigations related to customer complaints and non-conformances (NCR), providing valuable recommendations and feedback to our Corrective and Preventive Action (CAPA) and Supplier Corrective Action Request (SCAR) teams. You will support organizational quality objectives by completing timely reviews and investigations of CAPAs, SCARs, and non-conformance issues. Your participation in targeted account initiatives will be crucial, as you may lead problem-solving projects and collaborate with cross-functional teams to develop and optimize solutions for process failures. Utilizing various investigative tools such as FMEA, risk assessments, and gap analysis, you will ensure that we meet the needs of our customers, including high-value clients. Effective communication of decisions and recommendations to both internal and external stakeholders will be a key aspect of your role. As a resource for your colleagues, you will explain the use of investigative tools like the Ishikawa (Fishbone) Diagram and the 5-Why method, and you may assist in training cross-functional teams on best practices for problem-solving within their areas of responsibility. This position is not only about maintaining quality but also about fostering a culture of continuous improvement and collaboration within our global team.

Responsibilities

  • Drive root cause investigations related to customer complaints and non-conformances (NCR).
  • Provide recommendations and feedback to CAPA/SCAR teams.
  • Support organizational quality objectives, metrics, and reporting through timely completion of CAPA/SCAR reviews and investigations.
  • Participate in targeted account initiatives, including customer complaints and process failure investigations.
  • Lead cross-functional efforts as the Quality representative to develop and maintain solutions for process failures.
  • Utilize tools such as FMEA, risk assessments, and gap analysis to meet customer needs.
  • Communicate decisions and recommendations effectively to stakeholders.
  • Act as a resource for colleagues in using investigative tools and methodologies.
  • Advise and assist in training cross-functional teams on problem-solving approaches.

Requirements

  • Bachelor's degree in engineering or scientific field.
  • Minimum of 4 years of Quality Engineering work experience in a regulated environment (e.g., ISO 9001/ISO 13485).
  • Proficiency in problem-solving methodologies and tools for driving investigations.
  • Experience in designing and executing experiments to assist in root cause analysis.

Nice-to-haves

  • Six Sigma Green Belt Certification.
  • Experience working within cross-functional teams to determine root causes and mitigations for complex issues.
  • Direct experience working with customers.

Benefits

  • Paid time off
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Retirement benefits
  • Bonus/incentive pay
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