Quality Assurance Director

**QUALITY ASSURANCE DIRECTOR**

**Location**: Mexico (Multisite Operations)
**Company**: Leading US Medical Device Manufacturer

**Position Overview**:
The Quality Assurance Director plays a pivotal role in overseeing the quality and regulatory compliance for multisite manufacturing operations in Mexico. Reporting directly to the global executive team, this senior leadership role is responsible for designing and implementing quality assurance strategies, ensuring product excellence, and driving a culture of compliance and continuous improvement. The Director will act as a key influencer in aligning quality initiatives with corporate objectives, safeguarding the company’s reputation for delivering safe and reliable medical devices to global markets.

**Key Responsibilities**:
**1. Leadership & Strategic Direction**
- Provide visionary leadership to the quality assurance teams across multiple sites, fostering a culture of accountability, innovation, and excellence.
- Develop and execute a strategic roadmap for quality assurance that aligns with the company’s global objectives and regulatory standards.
- Serve as the primary quality representative to senior leadership and external stakeholders, including regulatory bodies and customers.

**2. Quality Management Systems (QMS)**
- Lead the implementation, harmonization, and continual improvement of ISO 13485-certified QMS across all manufacturing sites.
- Establish standardized processes, policies, and metrics to ensure consistency and compliance across operations.
- Drive audit readiness and lead internal and external audits, including FDA, ISO, and other regulatory inspections.

**3. Regulatory Compliance & Risk Management**
- Ensure full compliance with global regulatory requirements, including FDA 21 CFR Part 820, EU MDR, and applicable regional standards.
- Develop and manage a robust risk management framework, including Risk Analysis, Failure Mode and Effects Analysis (FMEA), and mitigation plans.
- Act as the primary point of contact for regulatory agencies, managing interactions, submissions, and inspection follow-ups.

**4. Continuous Improvement & Operational Excellence**
- Champion continuous improvement initiatives, utilizing Lean, Six Sigma, and other methodologies to enhance efficiency and reduce quality issues.
- Monitor quality performance metrics (e.g., CAPA, NCR, complaint trends) to identify opportunities for improvement and implement corrective actions.
- Collaborate with cross-functional teams to drive improvements in manufacturing processes, product quality, and customer satisfaction.

**5. Supplier and Vendor Quality Management**
- Oversee supplier and vendor qualification, audits, and performance reviews to ensure alignment with quality expectations.
- Develop strategic partnerships with key suppliers, fostering collaboration to improve material and component quality.

**6. Team Development & Leadership**
- Build and lead a high-performing quality assurance team by recruiting, mentoring, and developing talent.
- Establish clear objectives and KPIs for the quality team, ensuring accountability and alignment with corporate goals.
- Promote a culture of quality awareness and ownership at all organizational levels.

**Required Qualifications**:

- Bachelor’s degree in engineering, Quality Management, or a related field (Master’s or advanced degree preferred).
- A minimum of 12 years of progressive experience in quality assurance, with at least 5 years in a director or senior leadership role in the medical device industry.
- Extensive knowledge of ISO 13485, FDA regulations (21 CFR Part 820), EU MDR, and other relevant global regulatory standards.
- Proven track record of managing quality systems in a multisite manufacturing environment.
- Certifications such as CQE, CQA, or Six Sigma Black Belt are highly desirable.

**Key Competencies**:

- **Strategic Leadership**: Ability to provide vision and direction to quality assurance initiatives on a global scale.
- **Regulatory Expertise**: Comprehensive understanding of global medical device regulations and industry best practices.
- **Analytical Skills**: Data-driven decision making with the ability to analyze complex quality metrics and trends.
- **Communication**: Strong interpersonal and communication skills in English and Spanish to engage with diverse teams and stakeholders.
- **Problem-Solving**: Proactive approach to identifying and resolving complex quality and compliance challenges.
- **Cultural Sensitivity**: Experience working in multicultural environments, fostering collaboration and alignment across diverse teams.

**What We Offer**:

- Competitive executive compensation and benefits package.
- Leadership role with the opportunity to shape the future of quality assurance for a leading global medical device manufacturer.
- Professional growth and development opportunities in a dynamic, innovative environment.

**Note**: The position requires frequent travel within Mexico and occasiona