Quality Engineer

Biochemistry, Biomedical engineering, Chemical engineering, Chemistry, Communication skills, Documentation, Engineering, ISO 13485, Inspection, Investigation, Medical devices, Mechanical engineering, Materials science, Statistics, Research and development, Manufacturing, Leadership, GMP, mechanical drawings
Contract W2, 6 Months
$25 - $28
Work from home not available Travel required to 10%.

Job Description

Essential Duties and Responsibilities

  • Provide quality engineering support to manufacturing lines, including floor support, non-conforming product investigations, change order control requests reviews, and new equipment qualifications.
  • Perform return product investigations for product complaints.
  • Own key deliverables in support of development and continuous/sustaining engineering R&D projects, which may include: first articles, mold tool qualifications, component qualifications, shelf life validations, and sterilization validations.
  • Work with manufacturing and R&D engineers to prepare manufacturing work instructions, material specifications, and inspection documentation. Set inspection requirements, set inspection methods and inspection sampling plans.
  • Support quality control inspectors with new product inspections and quality issues that arise during inspections.
  • Provide leadership for nonconformance investigations and CAPAs and assigned.
  • Support internal audits and supplier audits.

Qualifications * Self-motivated worker, persistent, curious

  • Strong communication skills
  • Working knowledge and understanding of mechanical drawings
  • Strong problem solving, technical writing, and statistical analysis skills
  • Preferred experience with supporting a manufacturing product line
  • Preferred experience with tissue products
  • Desired experience with sterilization processes.

Education and/or Experience * B.S. degree in Engineering or Science (Biomedical Engineer, Chemical Engineer, Chemistry, Biochemistry, Materials Science)

  • 3+ years in an engineering role within a Medical Device company. Must have working experience of GMP and ISO 13485 requirements

Posted By

Victoria Clark

1000 Revolution Technologies, Way Melbourne, FL, 32901

Dice Id : vitalt
Position Id : 63457
Originally Posted : 1 month ago
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