INGENIERO DE ASEGURANZA DE CALIDAD

BD; Heroica Nogales; Vor Ort; MXN 360.000 - 480.000; Vollzeit

Zusammenfassung

BD is seeking a Quality Assurance professional to support inspection and manufacturing processes at the Nogales facility. You will evaluate test methods, establish validations, and review process and product validations to ensure high quality standards.

The role emphasizes CAPA investigations, risk analyses, and participation in continuous improvement under GMP and ISO 13485 frameworks. Fluency in English is beneficial, and MS Office proficiency is required.

Qualifikationen

• Bachelor's degree in Engineering or related field.
• 2 years in a similar role preferred.
• Proficient with statistics and MS-Office applications.

Aufgaben

• Supports inspection and manufacturing processes.
• Evaluates, improves, and implements test methods and inspection procedures.
• Establishes and executes test method validations.
• Reviews and approves process/product validations.
• Develops risk analyses for waivers/reworks/sorts.
• Leads CAPA investigations and implements corrective actions.

Kenntnisse

SPC

Statistics

Method validation

Ausbildung

Bachelor's degree in Engineering

Tools

MS Office

Jobbeschreibung

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Support for Inspection and Manufacturing processes
  • 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.
• Customer Complaints
  • Coordinates periodic meetings to evaluate customer complaints trend and action plans to reduce recurrence of failures.
  • Provides support to respond customer complaint investigations as team member.
  • Evaluates complaints to determine applicability to manufacturing/ supplier.
  • Performs investigations to address failures and/or trends reported by customers.
• Investigations/Action Plans
  • 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.
• External Rejections
  • Investigates and responds external rejection reports (SCARs/ QNs/ etc).
  • Reviews external rejection reports to generate action plan to reduce/mitigate incidences.
• Miscellaneous
  • 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.

Education and Experience:

• 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).

Language skils

Intermediate.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

MEX Nogales South - Parque Industrial El Cid