Principal Quality Specialist - CDMX

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.

Boston Scientific is a diverse company that is committed to empowering women, the LGBTQ+ community, and people with disabilities. We believe that diversity is a strength, and we are dedicated to creating an inclusive environment where all employees can thrive. We are proud to be an equal-opportunity employer, and we welcome applications from all qualified candidates regardless of their background or identity.

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 cross-functional teams to implement quality improvement projects.
• Collaborate with the procurement team to add vendor to the approved list, evaluate and manage suppliers' quality performance. Participate in supplier audits, monitor supplier corrective actions, and ensure adherence to quality agreements.
• Participate in risk management activities, including risk assessments and risk mitigation planning. Work closely with the all other areas to identify and address potential quality risks.
• May act as backup or sanitary responsible for the warehouse
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Requisition ID: 564043

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!