Global QMS Leader - Medical Devices & Compliance

Teleflex; United States; Presencial; USD 153 000 - 175 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, prescription, dental and vi s

Vision insurance

401(k) savings plan

Paid time off

Disability & parental leave

Flexible spending accounts

Resumo da oferta

Ingenyx seeks a Senior Quality Management Systems (QMS) Manager to lead and continuously improve our global medical device QMS. This role provides governance for regulatory compliance, supplier quality, internal audits, digital quality systems, and cross-site strategic initiatives.

The ideal candidate blends deep QMS expertise with regulatory judgment, people leadership, and a track record of driving change across a multinational organization. This is a senior leadership role within Ingenyx.

Qualificações

• Bachelor's degree in Quality, Engineering or Life Sciences with 10+ years of quality experience in medical devices.
• 5+ years leading QMS programs or major Quality System initiatives and 5+ years of people management.
• Advanced knowledge of ISO 13485 and FDA medical device QMS requirements.

Responsabilidades

• Lead global QMS governance, harmonization, and continuous improvement across sites.
• Oversee regulatory surveillance, gap assessments, and implementation of new requirements.
• Govern core QMS processes: CAPA, change control, document control, training, management review, metrics.
• Oversee Supplier Quality program governance, SCARs, and supplier risk.
• Lead Internal Audit Program: planning, execution, reporting, follow-up.
• Drive electronic QMS and document control within ERP/eQMS; ensure software validation.
• Provide quality oversight for software assurance/validation of quality systems.
• Ensure inspection readiness and drive continuous improvement using metrics and risk data.
• Serve as senior QMS SME during FDA, Notified Body, MDSAP, and customer audits.

Conhecimentos

QMS governance

Regulatory judgment

People leadership

Internal auditing

Quality metrics

Cross-functional collaboration

Digital Quality Systems

Risk management

Formação académica

Bachelor's degree in Quality/Engineering/Life Sciences

10+ years quality experience

5+ years leading QMS programs

ISO 13485 knowledge

FDA medical device QMS knowledge

Regulatory inspections experience

Ferramentas

eQMS/ERP systems

CAPA systems

Document control software

Descrição da oferta de emprego

Ingenyx seeks a Senior Quality Management Systems (QMS) Manager to lead and continuously improve our global medical device QMS. This role provides governance for regulatory compliance, supplier quality, internal audits, digital quality systems, and cross-site strategic initiatives.

The ideal candidate blends deep QMS expertise with regulatory judgment, people leadership, and a track record of driving change across a multinational organization. This is a senior leadership role within Ingenyx.