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What you will do

• Build relationships with various divisions and business units.

• Drive continuous improvement opportunities in Quality Assurance including cost reductions.

• Lead initiatives and projects to enhance quality performance and ensure compliance with regulations and standards.

• Work closely with operations and business functions to ensure quality performance of products and processes.

• Provide oversight and approval of NC (nonconformances) & CAPA (corrective action/preventative action) and mentor in problemsolving and root cause analysis.

• Coach and develop less experienced engineers.

• Participate in internal and external audits providing effective narrative and expertise.

• Apply statistical methods to ensure the reliability of the manufacturing process.

What you will need:

Required:

• Bachelors Degree in Engineering (Biomedical Mechanical or related field)

• 4 years of experience in a regulated industry

• 4 years of experience in Quality Assurance and continuous improvement

• 4 years of experience with process and equipment validation/qualification

Preferred:

• Internal Quality Auditor Qualification (ISO 13485 CFR 820 or comparable standards)

• Knowledge of PFMEA (process failure mode and effects analysis) validation programs and SPC (statistical process control) processes