Sr. Quality Assurance Engineer (Medical Industry)

BEPC Inc. - Business Excellence Professional Consulting; Guadalupe; On-site; MXN 400,000 - 700,000; Full time

Job summary

BEPC Inc. – Business Excellence Professional Consulting seeks a Senior Quality Assurance Engineer in Mexico to drive compliance and continuous improvement in a regulated manufacturing setting.

You will lead CAPA management, audits, change control, and risk analysis, applying Lean Six Sigma, DOE, and TMV to prevent defects and improve product quality. You will collaborate with Production, Engineering, and other plant functions to ensure the integrity of design, materials, and processes as changes

Qualifications

• Bachelor’s degree or higher in Industrial, Biomedical, Mechanical, Chemical, Electrical, or Mechatronics Engineering or related field.
• 3+ years of experience establishing, controlling, and improving Quality Systems.
• Knowledge of statistical methods and familiarity with Lean Six Sigma or continuous improvement.
• Experience in Medical Device or Pharmaceutical manufacturing preferred.
• ISO 13485, ISO 9001, or ISO 17025 certification preferred.
• Experience in problem solving, investigations, test analysis, and disposition of nonconforming products.
• Knowledge of Change Control systems and risk analysis.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Teams).
• Strong leadership and communication skills with a data-driven, collaborative mindset.

Responsibilities

• Ensure compliance with quality standards.
• Establish and maintain quality systems.
• Prevent product and process defects.
• Lead quality audits.
• Manage CAPAs.
• Support process and product validation activities.
• Lead improvements using Six Sigma, DOE, TMV, and IQ/OQ/PQ.
• Interact with customers on complaint investigations and analysis.
• Coordinate with cross-functional teams.

Skills

Lean Six Sigma

Statistical methods

Problem solving

Leadership

Communication

Data-driven

Teamwork

MS Office

Education

Bachelor’s degree in Industrial, Biomedical, Mechanical, Chemical, Electrical, or Mechatronics Engineering

Tools

Microsoft Office

Job description

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

The Senior Quality Assurance Engineer will be responsible for ensuring compliance with and continuous improvement of quality systems and standards, ensuring product and process conformity within a regulated manufacturing environment. This position will play a key role in CAPA management, audits, change control, risk analysis, quality investigations, and process and product validation activities (IQ/OQ/PQ, PPQ, and TMV). The role will also collaborate cross-functionally with Production, Engineering, and other plant functions, applying statistical tools and methodologies such as Lean Six Sigma and DOE to prevent defects, solve quality issues, and drive improvements in product quality and performance.

KEY RESPONSIBILITIES:

• Ensure compliance with quality standards.
• Establish and maintain quality systems.
• Prevent product and process defects.
• Lead quality audits.
• Manage Corrective and Preventive Actions (CAPAs).
• Support process and product validation activities.
• Drive quality improvements for existing products through the use of continuous improvement methods and tools, including Six Sigma, Product and Process Understanding (PPU), Design of Experiments (DOE), Customer Quality Index (CQI), Test Method Validation (TMV), and manufacturing line validation (IQ, OQ, PQ, and PPQ).
• Support and interact with customers through complaint investigations, problem-solving and trend analysis, test investigation and analysis, and disposition of nonconforming products.
• Lead and/or support internal and external audits.
• Ensure that the design intent and integrity of marketed products are maintained as materials, processes, methods, and specifications change.
• Support changes related to quality-driven design improvements, supply source changes, and cost-reduction initiatives.
• Represent the voice of the customer and help promote and foster a quality-focused environment and mindset throughout the organization.
• Coordinate with other plant functions, including Production, Facilities, MRO, EHS, and other cross-functional teams.

QUALIFICATIONS:

• Bachelor’s degree or higher in Industrial, Biomedical, Mechanical, Chemical, Electrical, or Mechatronics Engineering, Microbiology, or a related scientific discipline from an accredited institution.
• 3+ years of related experience establishing, controlling, and improving Quality Systems.
• Knowledge of statistical methods and familiarity with Lean Six Sigma and/or continuous improvement methodologies.
• Previous quality experience in a Medical Device or Pharmaceutical manufacturing environment is preferred.
• Certification in ISO 13485, ISO 9001, and/or ISO 17025 standards is preferred.
• Experience in problem-solving, investigations, test analysis, and disposition of nonconforming products.
• Knowledge of Change Control systems and risk analysis.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Teams, and related tools.
• Strong leadership and communication skills, with a results-oriented, teamwork-focused, data-driven, and people-focused approach.