Quality Engineer III

Quality Engineer III position focused on ensuring manufacturing quality and regulatory compliance across operations. The role combines technical expertise with quality oversight to maintain robust management systems, lead investigations, support validation activities, and drive continuous improvement in a GMP-regulated environment.

Responsibilities

• Lead quality investigations and remediation activities across manufacturing operations
• Support process validation programs, equipment qualification, and continued process verification
• Manage corrective actions, effectiveness checks, and internal/external audits
• Conduct risk assessments, gap analyses, and implement quality improvement initiatives
• Interface with internal teams and external customers/regulators on quality and compliance matters

Requirements

• Advanced degree plus 3 years quality assurance experience, or bachelor's degree plus 5 years in regulated industry
• Strong knowledge of cGMP, ISO 13485/9001, and FDA/EMA regulatory requirements
• Experience with process validation including protocol execution and process qualification
• Expertise in CAPA, deviation management, change control, and risk assessment/FMEA
• Advanced problem-solving, root cause analysis, and statistical analysis skills
• ASQ certifications (CQE, CQA) desired; proficiency with quality management software and MS Office

Compensation: $75,800–$113,675 base