Director, Service & Repair Quality
Johnson & Johnson
19 days ago
On-site
Danvers, MA
Operations
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.
Application instructions:
- Apply to the relevant requisition number(s) (applications considered a single submission). External accommodation request: https://www.jnj.com/contact-us/careers; internal employees contact AskGS.
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.
Application instructions:
- Apply to the relevant requisition number(s) (applications considered a single submission). External accommodation request: https://www.jnj.com/contact-us/careers; internal employees contact AskGS.