Quality Assurance Engineer

hace 3 semanas

Parque Industrial, México BD A tiempo completo

Job Description Summary

The Quality Engineer is responsible for providing support to the operative personnel for in-process
inspection, as well as the manufacturing related departments. The Quality Engineer role is to evaluate and
improve the QA acceptance activities and testing to ensure that medical devices being manufactured comply
with all the established requirements. He serves as a lead and support to investigations were deviations
have/ or can occur to the medical devices and require an action plan to prevent further impact on product,
this with the knowledge on regulations, standards, procedures, and by having a risk-based approach when
determining the corrections and actions required to ensure the quality and compliance of the product.

Job Description

How about becoming a maker of possible?

For more than 125 years, we’ve pursued our Purpose of advancing the world of health. We relentlessly commit to a promising future by developing innovative technologies, services and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD, from the manufacturing to marketing of our products, to look at the impossible and find transformative solutions to turn dreams into possibilities - For people today, tomorrow and beyond. Become a maker of possible with us

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.

Finished bachelor’s degree, in the Engineering area preferably.
2 years in a similar position preferably.
Knowledge of statistics techniques, and statistical process control (SPC).

Data analysis, problem solving, time management, teamwork, leadership skills.
Math abilities at professional level, statistical interpretation for decision making.

Language Skills: Intermediate English

“BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.”

**Required Skills**:
Optional Skills


Primary Work Location

MEX Nogales South - Parque Industrial El Cid

Additional Locations

Work Shift

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