BD (Becton, Dickinson and Company) Staff Quality Engineer I in Sandy, Utah
Job Description SummaryAs directed by the Quality Manager, the Staff Quality Engineer I is accountable for quality assurance in a particular manufacturing area by developing and maintaining quality control plans, dealing with non-conforming material, customer complaints, CAPAs and providing quality metrics to manufacturing and quality management. This position assures the manufacturing areas are compliant to regulations and GMP and support continuous improvement activities for improved quality and production.
Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measureable / confirmed results.
Track record of root cause determination and effective corrective and preventive action implementation.
Provides training for operations and engineering teams on best practices.
Conducts audits as member of a quality system audit team.
Writes and leads risk management activities.
May perform other duties as required.
POSITION SPECIFIC OVERVIEW
Support the implementation of new products, processes, and changes by developing quality plans, approval of validation plans and protocols, inspection methods, work instructions, and raw material specifications and inspection plans.
Analyze and interpret inspection and process data to identify continuous improvement opportunities and prevent quality problems.
Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material.
Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints.
Support manufacturing and quality process improvement projects as an effective team member or leader using continuous improvement and six sigma tools.
Develop working knowledge of applicable regulatory, corporate and unit requirements.
Facilitate change control.
Conduct internal and supplier audits. Provide audit support for customer and regulatory audits (preparation, closure, etc.).
Communicate across functions and departments for assigned areas of responsibility.
Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- May supervise quality technician activities.
EDUCATION AND EXPERIENCE REQUIREMENTS
Extensive knowledge of applicable regulatory, corporate and unit requirements.
Leadership, project management, and advanced communication skills required.
Training in design of experiments and statistics.
Class II / III medical device experience or pharmaceutical experience (preferred).
Knowledge of design control principles (preferred).
Knowledge of six sigma methodology (preferred).
ASQ certified quality engineer (CQE) or certified quality auditor (CQA) (preferred).
Typically requires a minimum of a Bachelor’s Degree in engineering or a scientific discipline.
A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.
Primary Work LocationUSA UT - Sandy
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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