FDA/ISO-Focused Quality Engineering Leader

Pci Pharma Services; Rockford (IL); On-site; USD 108,690 - 136,200; Full time

Benefits offered by this job

401(k) plan

Health insurance coverage

Paid time off

Flexible spending account

Job summary

Pci Pharma Services is seeking a Quality Engineering Leader to oversee and provide strategy for the Quality Engineering teams supporting advanced drug delivery. The ideal candidate will have a minimum of 5 years experience in an FDA regulated industry, particularly in medical device or combination products.

This role requires strong leadership skills, the ability to manage design transfer processes, and uphold quality standards. A competitive salary and benefits package are offered, including paid time off and health insurance.

Qualifications

• 5+ years of experience in an FDA regulated industry.
• Fluent English proficiency required for professional communications.
• Experience with statistical analysis and technical documentation.

Responsibilities

• Provide leadership for the Quality Engineering teams.
• Oversee design transfer/control and assurance procedures.
• Accountable for quality-related investigations.
• Lead the New Product Introduction process.

Skills

Root Cause Analysis (RCA)

Analytical skills

Communication skills

Computer software proficiency

Organizational skills

Education

College or Trade Degree in engineering or related scientific field

Tools

MS Office

ERP systems

eQMS systems

Job description

Pci Pharma Services is seeking a Quality Engineering Leader to oversee and provide strategy for the Quality Engineering teams supporting advanced drug delivery. The ideal candidate will have a minimum of 5 years experience in an FDA regulated industry, particularly in medical device or combination products.

This role requires strong leadership skills, the ability to manage design transfer processes, and uphold quality standards. A competitive salary and benefits package are offered, including paid time off and health insurance.