Senior Quality Engineering Leader — Design & Risk

PCI TRGR Penn Pharmaceutical Services Ltd; Rockford (IL); On-site; USD 108,690 - 136,200; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Flexible spending account

Job summary

PCI seeks a Sr. Manager, Quality Engineering to lead QA Engineering across Rockford sites. You will guide design transfer, risk management, and continuous improvement initiatives within a regulated medical device environment.

You will own data-driven quality initiatives, investigations, and supplier quality metrics, while partnering with multiple teams to ensure compliance with ISO 13485, FDA 21 CFR 820, and related standards.

Qualifications

• Engineering degree or related scientific degree.
• 5+ years of FDA-regulated industry experience.
• Proficiency with ERP and eQMS systems; ability to interpret data.

Responsibilities

• Lead Quality Engineering teams across Rockford Linden sites focusing on design transfer, control and risk management.
• Oversee investigations, deviations, supplier quality metrics, and CAPA processes.
• Drive MSAs, test method validation and V&V strategies; support regulatory inspections and audits.

Skills

Quality leadership

Root Cause Analysis

Statistical analysis

Lean Six Sigma

Cross-functional leadership

Project management

Education

Engineering degree or related scientific degree

Tools

ERP systems

eQMS systems

MS Office

Job description

PCI seeks a Sr. Manager, Quality Engineering to lead QA Engineering across Rockford sites. You will guide design transfer, risk management, and continuous improvement initiatives within a regulated medical device environment.

You will own data-driven quality initiatives, investigations, and supplier quality metrics, while partnering with multiple teams to ensure compliance with ISO 13485, FDA 21 CFR 820, and related standards.