Senior Quality Engineering Manager — Global Impact

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; On-site; USD 109,000 - 136,000; Full time

Benefits offered by this job

Health insurance

Vision and dental

401(k) plan

Paid time off

Flexible spending account

Job summary

PCI Pharma Services is seeking a senior Quality Engineering leader to oversee QE teams across Rockford Linden sites, guiding design transfer, risk management and product quality initiatives. You will drive resource planning, CAPAs and change controls within ISO 13485 and FDA 21 CFR 820 compliant systems.

You will mentor Quality Engineers, advocate data-driven decisions using MSA, GR&R, and RCA methods, and partner with operations, validation and regulatory teams to ensure on-time product

Qualifications

• Minimum 5+ years in an FDA-regulated industry (medical device or combination products).
• Engineering or related scientific degree required; Fluency in English.
• Proficient with ERP/eQMS software and MS Office; strong technical writing.
• Experience with RCA, MSA/GR&R, risk management and design controls.

Responsibilities

• Provide strategy and leadership over QE teams for design transfer, risk management and quality projects.
• Oversee NPI and tech transfer for product launches and sustaining products.
• Manage resource allocation and workload planning for QE staff.
• Serve as SME for Design Control and risk management in the QMS per ISO 13485 and FDA 21 CFR 820.
• Lead investigations, CAPAs and supplier quality across sites.

Skills

QE leadership

FDA-regulated experience

Root Cause Analysis

Statistical analysis

MSA / GR&R

Technical writing

Lean Six Sigma

Education

Engineering degree or related scientific degree

Tools

ERP systems

eQMS systems

Job description

PCI Pharma Services is seeking a senior Quality Engineering leader to oversee QE teams across Rockford Linden sites, guiding design transfer, risk management and product quality initiatives. You will drive resource planning, CAPAs and change controls within ISO 13485 and FDA 21 CFR 820 compliant systems.

You will mentor Quality Engineers, advocate data-driven decisions using MSA, GR&R, and RCA methods, and partner with operations, validation and regulatory teams to ensure on-time product