Job Description: SummaryThe Quality Engineer II will manage the Quality function 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 will also assure the manufacturing areas are compliant to required regulations and support continuous improvement activities.
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 and prevent quality problems and continuous improvement opportunities.
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/or Unit requirements.
Facilitate Change Control. Conduct Internal and Supplier Audits. Provide audit support for customer and regulatory audits (preparation, closure, etc.)
Communicates across functions / 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.
Other duties as assigned.
EDUCATION AND EXPERIENCE REQUIREMENTS
Requires a minimum of a Bachelor's Degree. (Engineering or Science preferred)
A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience.
Moderate knowledge of applicable regulatory requirements.
Training in statistics.
PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS
Class II / III medical device experience (preferred).
Knowledge of design control principles (preferred).
Ability to provide support to internal / external audits
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
Primary Work LocationUSA UT - Sandy
BD (Becton, Dickinson And Company)