Quality Engineer - CAPA & Root-Cause Leader

Actalent; Mechanicsburg (Cumberland County); On-site; USD 60,000 - 70,000; Full time

Benefits offered by this job

Health insurance

Retirement options

PTO 10 days

Job summary

Actalent in Mechanicsburg, PA seeks a detail-oriented Quality Specialist to improve manufacturing processes. You will lead root cause investigations, drive CAPA initiatives, and implement process improvements across production lines.

The role involves coordinating with production teams, supporting quality systems, and conducting customer audits to ensure compliance with GMP and ISO standards. Mon-Fri, onsite with competitive benefits.

Qualifications

• 3+ years in Quality Engineering/Assurance within manufacturing, ideally medical device sector.
• Experience leading root cause investigations and CAPA.
• Familiarity with quality systems and audits.

Responsibilities

• Lead root cause investigations to identify and resolve quality issues.
• Drive CAPA initiatives to enhance product quality.
• Implement manufacturing process improvements for efficiency and compliance.
• Conduct and support customer audits, ensuring adherence to quality standards.
• Engage with production teams to promote continuous improvement.
• Support quality systems management and regulatory compliance.

Skills

Quality assurance

Quality engineering principles

CAPA processes

Root cause analysis

Supplier quality management

Medical device manufacturing

GMP

Quality control processes

ISO standards

Job description

Actalent in Mechanicsburg, PA seeks a detail-oriented Quality Specialist to improve manufacturing processes. You will lead root cause investigations, drive CAPA initiatives, and implement process improvements across production lines.

The role involves coordinating with production teams, supporting quality systems, and conducting customer audits to ensure compliance with GMP and ISO standards. Mon-Fri, onsite with competitive benefits.