Quality Assurance Engineer - Medical Devices & CAPA

Becton, Dickinson and Company; Veracruz; On-site; MXN 320,000 - 520,000; Full time

Job summary

Becton, Dickinson and Company in Nogales Mexico is seeking a Quality Assurance professional to support inspection and manufacturing processes. You will evaluate and improve test methods, validate procedures, and participate in CAPA actions to prevent defects.

Responsibilities include handling customer complaints investigations, external rejections, and maintaining compliance with GMP and ISO 13485 standards, with a focus on continuous improvement and cost reduction.

Qualifications

• Finished bachelor’s degree, in the Engineering area preferably.
• 2 years in a similar position preferably.
• Computer and MS-Office applications handling.
• Knowledge of statistics techniques, and statistical process control (SPC).
• Lenguage skils: Intermediate.

Responsibilities

• Performs evaluation, improvement, and implementation of test method and inspection procedures used for acceptance activities, based on established standards, and established documents.
• Establishes and executes test method validations.
• Reviews and approves of process/ product validations.
• Develops Risk Analysis for Waivers/ Reworks/ Sorts/ Use as is/ etc.
• Leads/supports CAPA investigations to address root cause and generate action plans.
• Performs corrective/ preventive actions as well as effectiveness check for action plans.
• Investigates potentials for failure to detect risk to the product/ process.
• Investigates and responds external rejection reports (SCARs/ QNs/ etc).
• Reviews external rejection reports to generate action plan to reduce/mitigate incidences.
• Participates as support in projects for changes (design and non-design).
• Develops and updates the Process Failure Mode Effect Analysis (FMEA).
• Evaluates and proposes changes that contribute to the department costs reduction.
• Participates actively in the implementation of quality programs that encourage a prevention environment and defects or problems detection.
• Participates actively in the verification of the quality system to ensure the maintenance record in ISO 13485 certification, compliance of current Good Manufacturing Practices (GMP) and adherence to regulations and internal, divisional, corporate, and regulatory agencies policies.
• Proposes or recommends changes for continuous improvement of processes, products, procedures, and methods.
• Attends training courses, and or of self-professional improvement.
• Any other task assigned by immediate Supervisor or Manager.

Skills

Statistics techniques

Statistical process control (SPC)

Education

Bachelor's degree in engineering

Tools

MS Office

Job description

Becton, Dickinson and Company in Nogales Mexico is seeking a Quality Assurance professional to support inspection and manufacturing processes. You will evaluate and improve test methods, validate procedures, and participate in CAPA actions to prevent defects.

Responsibilities include handling customer complaints investigations, external rejections, and maintaining compliance with GMP and ISO 13485 standards, with a focus on continuous improvement and cost reduction.