Principal Quality Specialist

**Principal Quality Specialist - CDMX**:

- Remote Eligible: Hybrid- Onsite Location(s): Benito Juárez, DF, CMX, MX**Additional Locations**: N/A

**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.

**Career**: Pharmaceutical, Chemical, Biotechnology, Biomedical or science or engineering related field.

**Experience**: 3-5 years of experience executing Quality Assurance activities in any health-related (Medical devices preferred) company

**Other Qualifications**:

- Minimum of 3-5 years of experience in quality control/assurance in the medical device industry.
- Depth knowledge of relevant quality standards and regulations applicable to Medical Device Industry, such as COFEPRIS requirements, FEUM Medical device supplement, NOM-241, NOM-240, NOM-137, ISO 9001, ISO 13485.
- Understanding of quality control methodologies, statistical techniques, and process improvement methodologies (e.g., Lean, Six Sigma, Root Cause Analysis Techniques).
- Excellent analytical and problem-solving skills with the ability to interpret complex data and make decisions.
- Experience in leading and supervising teams, including training and development of personnel.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Attention to detail, organization, and a commitment to maintaining high standards of quality and compliance.
- Certified Quality Internal or Leader Auditor, other relevant certifications are a plus.
- High proficiency of English language B2 level.

**Activities and Skills Required for this Role**:
As a Quality Supervisor in the field of medical devices, you will be responsible for ensuring that all products meet regulatory requirements, industry standards, and internal quality guidelines. You will play a critical role in maintaining and improving the overall quality of the medical devices distributed by the company. Your primary focus will be on supervising the quality control and assurance processes to ensure the highest level of product quality and compliance.

The purpose of this role is to provide Quality expertise to support to the local/region/international business objectives as well as provide guidance to employees to facilitate continuous quality improvement. This role ensures compliance with Quality System activities (programs, policies, processes, procedures) to achieve stated objectives.

**Responsibilities**:

- Supervise Quality Control Processes: Oversee the day-to-day operations, ensuring compliance with established procedures, guidelines, and regulations. Monitor the receiving, inspection, returns, quarantine of medical devices at the warehouse to ensure adherence to specifications and quality standards.
- Interacts on a daily basis with local management (e.g. Supply chain, Sales, Customer Service, etc.) in all quality related matters.
- Manage complaints, actively manage the local execution of field corrective actions, ensures appropriate level of product traceability is maintained via oversight of the inventory management, local warehouse operation, product disposition decisions ,etc.
- Develop, implement & maintain quality assurance procedures, policies, and systems to maintain and improve product & process quality. Establish metrics and key performance indicators (KPIs) to measure quality performance and identify areas for improvement. Consolidate and report metrics of the QMR to the QA Manager & Participate in the Internal Audit process.
- Ensure compliance with all applicable regulatory requirements, such as COFEPRIS, FEUM, NOM-241, NOM-240, NOM-137, ISO 9001, ISO 13485 and other relevant industry regulations. Stay up to date with changes in regulations and industry best practices.
- Maintain accurate and comprehensive documentation related to quality assurance activities. Prepare reports, analyze data, and present findings to management, highlighting any quality trends, issues, or areas for improvement.
- Responsible for the delivery of quality and compliance related training to applicable employees at the local level and be champion for Quality and Compliance, driving an attitude of continuous improvement and customer satisfaction. Provide guidance and support to staff regarding quality-related matters, including training on quality standards, processes, and procedures.
- Drive continuous improvement initiatives to enhance product quality, efficiency, and customer satisfaction. Identify opportunities for process optimization, cost reduction, and waste elimination. Collaborate with cros