Quality Assurance Specialist
hace 4 semanas
Job Summary: We are seeking a highly skilled Quality Assurance Engineer to join our team at BD. As a Quality Assurance Engineer, you will be responsible for ensuring the quality and compliance of our medical devices.
Key Responsibilities:
- Support inspection and manufacturing processes
- Evaluate, improve, and implement test methods and inspection procedures
- Establish and execute test method validations
- Review and approve process/product validations
- Develop risk analysis for waivers/reworks/sorts/use as is/etc.
- Coordinate periodic meetings to evaluate customer complaints trend and action plans to reduce recurrence of failures
- Provide support to respond customer complaint investigations as team member
- Evaluate complaints to determine applicability to manufacturing/supplier
- Perform investigations to address failures and/or trends reported by customers
- Lead/support CAPA investigations to address root cause and generate action plans
- Perform corrective/preventive actions as well as effectiveness check for action plans
- Investigate potentials for failure to detect risk to the product/process
- Investigate and respond external rejection reports (SCARs/QNs/etc.)
- Review external rejection reports to generate action plan to reduce/mitigate incidences
Requirements:
- 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
- Intermediate English
What We Offer:
BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.
Primary Work Location: MEX Nogales South - Parque Industrial El Cid
Additional Locations:
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