Senior QA Specialist

TN Italy; Italia; Remoto; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An innovative company is seeking a Senior Quality Assurance Specialist to lead compliance activities and ensure regulatory standards are met. In this remote role, you will manage audits, guide auditors, and improve business processes within a collaborative environment. Join a team committed to excellence and continuous improvement, where your expertise will contribute to maintaining high-quality standards in medical devices. This position offers the opportunity to work with diverse teams across EMEA and APAC, making a significant impact on compliance and quality assurance.

Servizi

Paid Time Off

Flexible Schedules

Parental Leave

Competenze

• At least 5 years of experience in QMS and auditing.
• Knowledge of medical device standards and technical auditing.

Mansioni

• Manage the Inspection Readiness program and conduct audits.
• Lead Health Authority notification responses and maintain QMS.

Conoscenze

Quality Management Systems (QMS)

Auditing

Medical Device Standards (ISO13485:2016, FDA CFR 820)

Technical Auditing

Communication Skills

Fluency in English

Formazione

Bachelor's Degree

Descrizione del lavoro

Senior QA Specialist - Remote, Italy

Client: Advanced Sterilization Products

Location: Europe - Remote

Job Category: Other

EU work permit required: Yes

Job Reference: e49950bd0d68

Job Views: 2

Posted: 06.05.2025

Expiry Date: 20.06.2025

Job Description:

Role: This is an excellent career opportunity for a Senior Quality Assurance (QA) Specialist responsible for supervising and leading activities to ensure continuous compliance. The role involves working with internal and external partners mainly in EMEA and APAC regions for audits and inspections to minimize compliance risks.

Key Responsibilities:

• Manage the Inspection Readiness program to ensure the QMS operates in compliance, including training, site walks, and corrective actions.
• Conduct internal and supplier audits, including planning, execution, reporting, and follow-up.
• Participate in external audits and inspections.
• Lead Health Authority notification responses.
• Maintain QMS and product certificates, including documentation and requests.
• Track audit reports and metrics for leadership communication.
• Stay updated on regulatory trends and standards.
• Guide auditors-in-training and leverage external auditors.
• Evaluate and improve business processes.
• Perform special projects as needed.

Qualifications:

• Bachelor's Degree
• At least 5 years of experience in QMS and auditing
• Knowledge of medical device standards (ISO13485:2016, FDA CFR 820, EUMDR, MDSAP)
• Technical auditing knowledge
• Fluency in English
• Strong communication and presentation skills
• Ethical judgment, adaptability, and commitment to continuous improvement

Additional Information:

We value diversity and offer inclusive benefits, including paid time off, flexible schedules, and parental leave where available.

Our Culture:

Our culture is rooted in the ASPirational4 values: customer obsession, courage, building extraordinary teams, and delivering results. We are committed to continuous improvement, facing challenges head-on, and working together for a sustainable future.