Quality Engineer I – BD – Tempe, AZ

Primarily responsible for providing Quality Engineering support to Sustaining projects (e.g., MDR).

Essential Job Functions:

• Provide Quality Engineering representation on Product Development/Sustaining Teams.

• Initiate new/revised documentation and tracks through approval cycles and implementation.

• Participate on cross-functional teams to develop risk assessment.

• Develop physical and functional test methods to ensure specifications are met.

• Write and/or review design verification and validation protocols and reports.

• Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.

• Conduct and /or coordinate testing outlined in protocols and test methods.

• Perform process improvement, control and monitoring on manufacturing processes.

• Provide technical direction during design transfer activities.

• Conduct complaint investigations.

• Participate and provide input to training on department/division procedures, and policies.

• Participate in project planning, budgeting, scheduling and tracking.

• Participate in internal and supplier audits.

• Develop and implement procedures to provide easy to follow instructions.

• Understand and follow company procedures on regulatory requirements.

• Provide positive example and actively promote compliance to all standards.

• Maintain a professional working relationship with internal and external customer and support staff.

• Prepare and present project updates and technical discussions.

Basic Skills/Competencies Required:

• Working knowledge of FDA GMP/GLP, Medical Device Directive, and ISO.

• Ability to make and present engineering decisions

• Strong interpersonal skills

• Comparative statistics

• Ability to analyze and optimize manufacturing and quality systems

• Basic product, design & prototyping skills

• Ability to create and provide training

• Software application skills

• Problem solving ability

• Ability to create, review and coordinate test protocols and reports

• Ability to generate engineering proposals

• Oral and written presentation skills

• Ability to work on cross functional teams

• Must read, write and understand English. Must be detailed in handling information/data.

Education and Experience Required:

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

• Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

• While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.

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, or any other protected status.

USA AZ – Tempe Headquarters