Quality Assurance Engineer

4 hours ago


Mansfield, Ohio, United States Teleflex Full time
Job Description

Teleflex is seeking a Quality Assurance Engineer to support the development, implementation, and maintenance of the quality system. The successful candidate will drive continuous improvement initiatives, ensure manufacturing processes comply with regulatory and quality system standards, and collaborate with cross-functional teams to identify and resolve quality issues.

Key Responsibilities
  • Develop and implement process control plans and standard operating procedures (SOPs) to ensure consistent product quality throughout production.
  • Conduct process validation, ensuring that equipment and processes meet predetermined specifications and quality requirements.
  • Lead root cause analysis and implement corrective and preventive actions (CAPAs) to address non-conformances and improve process performance.
  • Support internal and external audits, ensuring production areas are audit-ready and maintain thorough documentation for compliance.
  • Monitor key performance indicators (KPIs) in manufacturing, driving continuous improvement initiatives to enhance process efficiency and product reliability.
Requirements
  • Bachelor's Degree in Engineering, Chemistry, Physical Science, or related field.
  • 3+ years of Quality Assurance experience working in the medical device manufacturing environment.
  • cGMP, QSR, ISO 13485 knowledge base required.
  • Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint.

Teleflex is an affirmative action & equal opportunity employer. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.



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