INGENIERO DE ASEGURANZA DE CALIDAD

7191 Productos Para el Cuidado de la Salud, S.A. de C.V.; 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

Job Responsibilities:

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).

Lenguage 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.

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

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

Additional Locations

Work Shift BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases.