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Quality Engineer - Design Control

Medical Device Company with manufacturing operations in northern Milwaukee Wisconsin currently have an opening for a permanent direct hire Quality Engineer.

The company develop & manufacturing class III devices. As the Quality Engineer you will develop & execute quality plans including risk assessments, manufacturing process quality & validation. As the Quality Engineer you will also work closely with the New Product Development team on design controls & design reviews to ensure quality compliance for new products as well as existing product design changes.

The company is expanding rapidly and this is a new role to the quality group.

Responsibilities:

  • Represent quality in product development projects to develop & execute quality plans, develop design control deliverables including product performance analysis, design verification, design validation, design reviews, phase reviews and product release authorization for distribution of products.
  • Review design inputs and outputs to assure and evaluate quality requirements.
  • Develop, review and approve product verification plans and test methods.
  • Support validation efforts of approved testing to assure compliance.
  • Participate in the change order process to review and approved engineering change requests.
  • Participate in the Material Review Board (MRB) to review and disposition non-conformances and to work with supplier quality to coordinate supplier corrective actions.
  • Work with manufacturing to coordinate and monitor production processes to ensure compliance to FDA, QSR, ISO 13485, MDR and other applicable regulatory requirements to ensure that safe and effective products are produced.
  • Provide validation support by applying manufacturing quality tools including but not limited to DFMEA, PFMEA, IQ, OQ, PQ, control plans, process verification/validation plans and root cause analysis.
  • Lead and participate in complaint investigations, failure analysis of returned products and issues in ship/stop production; document findings, provide reports and analysis, & document risk assessment.
  • Compile and institute quality metrics to present at meetings to trend, recommend and implement corrective actions and appropriate follow up.

Requirements:

  • Bachelor's degree preferably in an engineering discipline.
  • 3 years of experience in a quality engineering function with 3 years of design controls experience in the medical device field with FDA CFR 820 and ISO 13485.
  • Strong verbal & written communication skills is necessary to work with cross functional teams and manage projects effectively.

This is a permanent direct hire role, salary is depending on experience up to $80,000.

If you are interested and meet the requirements, please apply with your resume.

There is no relocation assistance available if you are not already in the Milwaukee area.

Sthree US is acting as an Employment Agency in relation to this vacancy.