Sr. Manager, Quality Engineering ADD

PCI Pharma Services seeks a senior manager to lead quality engineering teams across multiple sites in Rockford, overseeing design control, risk management, and quality assurance for advanced drug delivery products. The role requires strategic leadership, regulatory compliance expertise, and direct oversight of quality engineers supporting product launches and commercialized products.

Responsibilities

• Direct oversight and development of quality engineers across multiple sites with project assignment based on technical expertise
• Lead quality engineering support for new product introductions, technology transfer, and sustained commercialization
• Serve as subject matter expert and process owner for design control, risk management, and measurement system analysis procedures
• Oversee investigations, supplier nonconformances, and post-market surveillance feedback integration with design teams
• Manage resource allocation, budget planning, and performance metrics for up to 10 direct reports

Requirements

• Bachelor's degree in engineering or related scientific field
• Minimum 5+ years FDA-regulated industry experience, preferably medical devices or combination products
• Proficiency with MS Office, ERP systems, and eQMS platforms
• Advanced analytical and root cause analysis capabilities
• Fluent professional-level written and verbal communication skills
• Design control and ISO 13485/21 CFR 820 regulatory knowledge