Director, Service & Repair Quality

Director, Service & Repair Quality (Danvers, MA or Aachen, Germany) Key Responsibilities Drive continuous service & repair quality improvements; maintain compliance and provide global multi-site support. Lead delivery of critical Quality Control initiatives for serviceable medical devices. Implement key quality capabilities that differentiate the Quality organization. Coordinate regional efforts for compliance, technology investments, regulations, and resource management. Develop and grow the service & repair quality organization (talent acquisition and internal moves) to support forecasted growth. Promote awareness of regulatory and customer requirements across service/repair sites. Ensure Quality System is regularly audited/reviewed; implement required changes. Apply FDA and other regulatory/quality requirements (FDA QSR/GMP, CAPA, ISO 13485, MDD, CMDCAS, etc.) to service & repair systems. Create statistically sound sampling plans; analyze data to drive continuous improvement and resolve quality issues. Develop/maintain quality objectives; track and trend performance. Design and maintain risk management programs for service & repair. Lead compliance support during FDA/other regulatory inspections. Communicate business issues/opportunities to next management level. Follow Health, Safety, and Environmental guidelines and ensure personal/company compliance with applicable regulations and policies. Qualifications Education: BS (required) in Scientific/Engineering discipline; MS preferred. Experience (Required): 10+ years GMP-related experience in med device/biotech manufacturing with serviceable devices; 7+ years leading/managing quality with serviceable devices and associated teams at company/corporate level. Preferred Skills Business planning, inclusive leadership, ISO 9001, Lean supply chain management, process improvements, quality systems documentation, quality validation, non-conformance reporting (NCR). Benefits Annual bonus (target-based) or sales commissions; vacation days; parental leave (minimum 12 weeks); bereavement/caregiver/volunteer leave; well-being reimbursement; financial/physical/mental health programs; service anniversary/recognition awards; eligible dependents may participate in insurance plans. #J-18808-Ljbffr