Description

You will own the quality engineering function for product and process adherence.

This role is on-site.

Responsibilities

• Lead the development and implementation of quality programs ensuring product and process conformity to specifications and regulations.
• Drive continuous improvement efforts in Quality Controls to reduce recalls and maintain regulatory standards.
• Lead or participate in CAPA and non-conforming investigations, acting as the site Subject Matter Expert (SME).
• Partner with Operations, Regulatory, Product Development, Supplier Quality, and PMO to meet quality system requirements for product launches.
• Gather data and formulate strategy for risk activities, including MSA, GRR, and FMEA, and present findings for decision-making.

Required Skills

• Six years of quality engineering experience.
• Strong working knowledge of FDA and/or ISO regulations.
• Ability to assess and incorporate technical standards related to Quality Operations.
• Experience with Product Development and Supplier Quality processes.
• Familiarity with ASQ principles.
• Proficiency in SAP.

Preferred Skills

• Bachelor's degree in Engineering or related field.

Key Skills

Education

Bachelor's degree