Senior Product Quality Engineer: Post-Market CAPA Leader

Hologic, Inc.; Newark (DE); In loco; USD 119.000 - 187.000; Tempo pieno

Descrizione del lavoro

Hologic, Inc. is seeking a Product Quality Engineer to provide expert support for on-market medical devices. You will lead investigations, risk assessments, and root-cause analyses in response to field complaints, mentoring junior engineers and driving improvements across product lines.

The role requires deep regulatory knowledge, the ability to coach teams, and coordination with cross-functional stakeholders to ensure compliant quality systems and effective CAPA implementation.

Competenze

• Strong knowledge of FDA QMS (21 CFR 820) and ISO 13485.
• Experience leading complex investigations and CAPAs.
• Experience in FDA-regulated medical devices industry.

Mansioni

• Act as product quality engineer expert for assigned product lines.
• Lead complaint investigations, RCA, risk assessments and documentation.
• Coach engineers on procedures, data analysis, and problem-solving methods.
• Coordinate cross-functional teams to implement improvements or corrections.
• Present quality metrics to leadership and support external audits.

Conoscenze

Quality engineering

Root cause analysis

Project leadership

Mentoring

Data analysis

Regulatory knowledge

Formazione

Bachelor’s Degree in Engineering

Descrizione del lavoro

Hologic, Inc. is seeking a Product Quality Engineer to provide expert support for on-market medical devices. You will lead investigations, risk assessments, and root-cause analyses in response to field complaints, mentoring junior engineers and driving improvements across product lines.

The role requires deep regulatory knowledge, the ability to coach teams, and coordination with cross-functional stakeholders to ensure compliant quality systems and effective CAPA implementation.