Senior Quality Engineer (Instrument Plant)

About This Role

This Senior Quality Engineer role is responsible for ensuring product and process quality for designated instrument plant product lines. The role involves interpreting quality system policies, leading CAPAs, and driving continuous improvement in a fast-paced healthcare environment.

Responsibilities

• Interpret applicable Quality Systems policies, regulations, and plant-level procedures.
• Ensure plant practices, product processes, and documentation are compliant.
• Assess Critical To Quality (CTQ) parameters and make risk assessments for product disposition.
• Responsible for all aspects of product and process quality for designated Instrument Plant product lines.
• Develop and maintain the Design History File, product, and supplier quality.
• Initiate and/or support CAPAs and may lead the investigation/corrective action process.
• Responsible for ID/AST plant sustaining, validation, and NPD Quality Engineering.
• Assure departmental compliance with ISO, IVDR, and FDA requirements.
• Utilize tools for risk analysis/management, 8D, validation, and project management.
• Drive continuous improvement and participate in Continuous Improvement teams.

Requirements

• 5+ years' experience in the quality function (or 3+ years with Master's Degree)
• Bachelor's Degree in Biological Sciences, Chemistry, Regulatory Affairs or related field
• Experience handling multiple projects simultaneously
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)

Qualifications

• Bachelor's Degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field or Master’s Degree.
• Minimum of 5 years’ experience within the quality function with a Bachelor's Degree, or minimum of 3 years' experience with a Master's Degree.

Nice to Have

• Pharma/Medical device industry experience
• Experience with Minitab or other statistical analysis platforms

Skills

* Required skills

Benefits