PwC is recruiting on behalf of Integer
Quality Assurance Senior Manager, Medical Devices Ref. 9982
Location: Montevideo - Work model: Onsite
About the role:
We are seeking a Quality Assurance Senior Manager to lead the site Quality function and ensure compliant, high‑quality manufacturing of medical devices and components.
This position serves as the Site Management Representative, with full accountability for the establishment, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with Integer Quality Policies, FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and applicable Medical Device Directives.
This is a senior leadership role with high visibility and impact across operations, product lifecycle management, and continuous improvement initiatives.
Key responsibilities:
- Lead and maintain compliance with all applicable quality, regulatory, safety, and environmental requirements (QMS, EMS, FDA, internal policies).
- Develop, implement, and continuously improve the Quality Management System in alignment with FDA QSR and ISO 13485.
- Act as Management Representative, ensuring effective execution and regulatory readiness.
- Establish and lead internal and external audit programs.
- Oversee document control, record management, and product traceability systems.
- Lead Quality activities across the product lifecycle, including design transfer and post‑market surveillance.
- Drive CAPA, continuous improvement initiatives, and risk‑based quality processes to improve efficiency and reduce cost.
- Partner with Operations, R&D, Regulatory, and Commercial teams to support business and quality objectives.
- Align Quality resources with site productivity and operational goals.
- Lead, coach, and develop Quality managers, engineers, and technicians.
- Define and manage Quality strategy, KPIs, tactical plans, and departmental budget.
- Maintain strong relationships with internal and external stakeholders, customers, and suppliers.
Required qualifications:
- Bachelor’s degree in Engineering, Pharmaceutical Chemistry, or a related field.
- 10+ years of experience in technical or quality roles within regulated industries.
- 5+ years of people leadership experience.
- Strong knowledge of FDA QSR, ISO 13485, GMP, and Quality Systems.
- Advanced English proficiency.
Preferred qualifications:
- Master’s degree.
- Previous experience as a Quality Management Representative.
- Strong communication, leadership, and stakeholder management skills.
- Proactive mindset, autonomy, sense of urgency, and strong problem‑solving capabilities.
This role offers:
The opportunity to lead Quality at a strategic level within a highly regulated industry, make a tangible impact on business performance, and develop high‑performing teams in a dynamic manufacturing environment.
In accordance with Uruguayan Law No. 19,691 and Decree No. 73/019, applicants who meet the required qualifications will be considered without distinction.