Sr. Manager, Quality Engineering

Responsibilities

• Provide strategy and leadership over Quality Engineering (QE) teams at the Rockford and Linden sites, supporting design transfer/control/assurance, risk management, statistical analysis of data, deviations, complaints, change management, and quality improvement projects.
• Direct oversight and development of Quality Engineers for the Advanced Drug Delivery business segment, assigning them to projects based on technical expertise and project priority.
• Lead the QE team to support new product introduction and technology transfer for product launches, as well as the sustaining of commercialized products.
• Manage overall staffing, reviewing, planning, and administering resource allocation and workload planning for QE staff.
• Serve as subject‑matter expert and process owner for design control and risk management procedures within the Quality Management System, including a risk management program aligned to ISO
  14971.
• Oversee and approve investigations including calibration out‑of‑spec, laboratory or environmental monitoring product impact investigations.
• Approve site supplier nonconformances and supplier‑related quality metrics.
• Process owner for Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection Plans and techniques, GR&R, test requirements, and Test Method Transfer/Validation.
• Conduct technical evaluation of change controls, risk assessment, and implementation of risk mitigation strategies.
• Provide high‑level guidance on complex design validation and verification (V&V) strategies, sampling plans, and root‑cause investigations for design failure.
• Oversee the feedback loop between Post‑Market Surveillance (complaints) and internal or external design assurance teams to trigger necessary design changes or CAPAs.
• Act as the final quality approver for major “Stage Gate” transitions, ensuring all design inputs, outputs, and transfer activities are complete and compliant.
• Ensure design assurance strategies align with evolving global standards, including ISO
  13485 and FDA
  21CF
  R820.
• Apply scientific statistical analysis techniques to proactively identify trends, root causes, and implement actions to mitigate recurrence.
• Provide input for statistical assessment of data to drive continuous improvement.
• Support and maintain quality assurance programs, policies, procedures, and controls, ensuring products meet established standards and regulatory requirements.
• Participate in steering committees to guide and influence company focus on new products, customers, and strategic initiatives.
• Prepare reports for company management detailing the status of open projects that support capacity, regulatory, and quality improvement requirements.
• Present quality standards, process flows, inspection plans, and issues internally to stakeholders and externally to clients with confidence and accuracy.
• Ensure the QE team achieves compliance levels and develops actions to sustain performance through metrics and KPIs.
• Support recruitment, coaching, and development of Quality Engineers to achieve excellence and efficiency when programs scale.
• Create a learning culture that enables individuals to reach their maximum potential.
• Manage budget development and periodic projections of spending against budgets, controlling departmental spending.
• Partner with internal teams (Business Unit, Quality, Operations, Engineering, Validation) to achieve company goals.
• Participate in regulatory inspections, customer audits, visits, and conference calls.

• Lead a group of up to ten direct reports across multiple sites.

• College or trade degree required (engineering or related scientific degree).
• Minimum 5+ years of experience in an FDA‑regulated industry, preferably medical device or combination products.
• Proficiency with personal computers, MSOffice, and technical software (ERP and eQMS systems).
• Ability to create, use, and interpret scientific tables, charts, and graphs.
• Advanced computer skills for performing complex tasks across multiple programs.
• Full professional proficiency in speaking, reading, and writing fluently and accurately.
• Analytical ability to conduct effective root‑cause analysis and…