Manufacturing Quality Assurance Specialist

1 week ago


Zelienople, Pennsylvania, United States BD Full time
Job Summary

The Quality Engineer performs various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Quality Assurance.

The role provides guidance for the various elements of the Quality System, ensuring process control and identifying/recommending opportunities for continuous improvement.

Applies statistical tools to analyze data, identify root cause, and corrective actions for effective problem resolution of small to moderate in scope and complexity.

Supports internal and external audits, and coordinates communication between Division R&D and Plant personnel on new products, product improvements, and product issues.

Monitors product quality levels, waste, and rejection rates, and owns efforts to reduce and eliminate rejections.

Reviews and develops changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost.

Supports and assures appropriate CAPA activities to accomplish internal/external objectives.

Assists with the investigation and closure of applicable Non-Conforming Material Reports.

Supports the implementation of new processes and automation projects to the manufacturing floor.

Supports and recommends the disposition of all non-conforming products.

Other duties as required.

Key Responsibilities
  • Work with manufacturing engineers to solve problems that arise leading up to production.
  • Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality.
  • Maintains familiarity with manufacturing processes and products to evaluate the cause and effect of defects and identify trends in process and product quality.
  • Provides quality engineering project support with respect to generally accepted quality engineering tools/principles.
  • Conducts quality engineering investigations, calculations, and prepares reports for out of tolerance conditions.
  • Provides input to Test Methods and addresses Test Method Validation.
  • Provides guidance to test technicians/quality inspectors as required.
  • Provides assistance with internal and external quality system audits.
  • Provides technical guidance for projects using the application of FMEA's, risk mitigation, plant validations; DOE's, and other experiments and investigations as assigned.
  • Formulates, reviews, and implements policies and procedures relating to product quality and process control as appropriate.
Requirements
  • B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent.
  • Knowledge of QSR's/ISO 13485 and their application would be a plus.
  • A minimum of 1 year of experience in a manufacturing environment of related industry.
  • Professional Skills & Key Competencies: Knowledge of electronics assembly and test, ability to provide support to internal/external audits, ability to work in a fast-paced warehouse environment.
Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.

It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

We welcome people with the imagination and drive to help us reinvent the future of health.

At BD, you'll discover a culture in which you can learn, grow, and thrive.



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