Director, Service & Repair Quality
Johnson & Johnson
14 hours ago
On-site
Danvers, MA
Operations
Director, Service & Repair Quality (Danvers, MA or Aachen, Germany)
Key Responsibilities:
- Drive continuous quality improvements; maintain Service & Repair compliance; provide global multi-site support.
- Lead delivery of critical Quality Control initiatives for Service & Repair of Medical Devices.
- Identify and facilitate implementation of site capabilities to give the Quality organization a competitive advantage.
- Coordinate regional efforts related to compliance, technology investments, regulations, and resource management/optimization.
- Develop a world-class service & repair quality organization (talent acquisition/internal talent movements) to support forecasted growth.
- Promote awareness of regulatory and customer requirements across service and repair sites.
- Ensure the Quality System is regularly audited/reviewed and implement required changes.
- Apply FDA/regulatory knowledge to Service & Repair systems (FDA QSRs including GMP/CAPA; ISO 13485; MDD/CMDCAS; and national/international quality/regulatory standards).
- Develop statistically sound sampling plans; analyze data to drive continuous improvement and resolve quality issues.
- Develop/improve/maintain quality objectives; track and trend performance.
- Design/develop/maintain risk management programs for Service & Repair.
- Lead compliance support during FDA and other regulatory inspections.
- Communicate business issues/opportunities to next management level; follow Health, Safety, and Environmental guidelines; ensure compliance with regulations and company policies/procedures.
Qualifications:
- Education: B.S. (Scientific/Engineering) required; M.S. preferred.
- Experience (Required): 10+ years GMP-related 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, coaching, inclusive leadership, fact-based decision making, ISO 9001, Lean supply chain management, non-conformance reporting (NCR), process improvements, quality standards/systems documentation/validation, and STEM application.
Benefits (time off):
- Vacation: 120 hours/year; Sick time: 40 hours/year (CO 48; WA 56); Holiday pay (incl. floating): 13 days/year; Work/Personal/Family Time up to 40 hours/year; Parental Leave: 480 hours; Bereavement Leave: 240 hours (immediate) / 40 hours (extended); Caregiver Leave: 80 hours; Volunteer Leave: 32 hours; Military Spouse Time-Off: 80 hours/year.
Key Responsibilities:
- Drive continuous quality improvements; maintain Service & Repair compliance; provide global multi-site support.
- Lead delivery of critical Quality Control initiatives for Service & Repair of Medical Devices.
- Identify and facilitate implementation of site capabilities to give the Quality organization a competitive advantage.
- Coordinate regional efforts related to compliance, technology investments, regulations, and resource management/optimization.
- Develop a world-class service & repair quality organization (talent acquisition/internal talent movements) to support forecasted growth.
- Promote awareness of regulatory and customer requirements across service and repair sites.
- Ensure the Quality System is regularly audited/reviewed and implement required changes.
- Apply FDA/regulatory knowledge to Service & Repair systems (FDA QSRs including GMP/CAPA; ISO 13485; MDD/CMDCAS; and national/international quality/regulatory standards).
- Develop statistically sound sampling plans; analyze data to drive continuous improvement and resolve quality issues.
- Develop/improve/maintain quality objectives; track and trend performance.
- Design/develop/maintain risk management programs for Service & Repair.
- Lead compliance support during FDA and other regulatory inspections.
- Communicate business issues/opportunities to next management level; follow Health, Safety, and Environmental guidelines; ensure compliance with regulations and company policies/procedures.
Qualifications:
- Education: B.S. (Scientific/Engineering) required; M.S. preferred.
- Experience (Required): 10+ years GMP-related 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, coaching, inclusive leadership, fact-based decision making, ISO 9001, Lean supply chain management, non-conformance reporting (NCR), process improvements, quality standards/systems documentation/validation, and STEM application.
Benefits (time off):
- Vacation: 120 hours/year; Sick time: 40 hours/year (CO 48; WA 56); Holiday pay (incl. floating): 13 days/year; Work/Personal/Family Time up to 40 hours/year; Parental Leave: 480 hours; Bereavement Leave: 240 hours (immediate) / 40 hours (extended); Caregiver Leave: 80 hours; Volunteer Leave: 32 hours; Military Spouse Time-Off: 80 hours/year.