Senior Manager, Medical Device Quality & Regulatory

ABBVIE; Branchburg Township (NJ); Sur place; USD 125 000 - 237 000; Plein temps

Avantages offerts par ce poste

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Résumé du poste

AbbVie is seeking a Senior Manager, R&D Device Quality to lead quality activities for medical devices within combination products. You will guide design control, risk management and usability initiatives across development teams to ensure compliant, safe products.

You will collaborate with engineering, manufacturing and regulatory affairs to drive risk assessments, CAPA, and design verification/validation, while supporting audits and continuous improvement across the site.

Qualifications

• 10+ years’ experience in Medical Device industry with 2+ years in project management.
• BS in Engineering or Scientific discipline; MS preferred.
• Strong knowledge of Medical Device development activities.
• Proven expertise with interpreting and leading others in compliance with 21 CFR Part 820, ISO 13485, ICH Q9, 21 CFR 4, Canadian Medical Device Regulation, ISO 14971, MDD, EN 62366 and ANSI HE75.
• Skilled in requirements analysis with testable and measurable specifications.
• Familiar with reliability analysis and test methods.
• Good verbal and written communication, especially technical reporting.
• Ability to influence internally and with external partners.
• Experience interacting with regulatory agencies and notified bodies.
• Knowledge of CAPA, SPC, quality risk management, FMEA, DOE and other quality tools.

Responsabilités

• Provides quality system methodology guidance across design, development and change control.
• Participates in cross-functional teams evaluating design docs for quality, risk and manufacturability.
• Translates design requirements into manufacturing specs to achieve design for manufacturability.
• Acts as technical resource for investigations to drive root-cause analysis and corrective actions.
• Leads DRM-related activities: robust engineering, reliability predictions, CTQ’s and VOC.
• Ensures projects comply with FDA QSR, ISO 13485, ICH Q9 and other standards.
• Oversees clinical batch manufacturing QA, including qualification and batch release.
• Develops site QA strategies and improves design control and risk management; supports MDCP QMS and CAPA.
• Supports regulatory audits as SME; drives harmonization and data-driven improvements.
• Keeps current on global quality trends for pharma and medical devices.
• Supports updates to quality standards for conformance and continuous improvement.

Connaissances

Medical Device development

Quality systems

Risk management

FMEA

DOE

CAPA

Root cause analysis

Project management

Regulatory influence

Verbal/written communication

Formation

BS in Engineering or Scientific discipline

MS preferred

Outils

CAPA systems

FMEA

DOE

SPC

Description du poste

AbbVie is seeking a Senior Manager, R&D Device Quality to lead quality activities for medical devices within combination products. You will guide design control, risk management and usability initiatives across development teams to ensure compliant, safe products.

You will collaborate with engineering, manufacturing and regulatory affairs to drive risk assessments, CAPA, and design verification/validation, while supporting audits and continuous improvement across the site.