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BD (Becton, Dickinson and Company) Quality Engineer I in Tempe, Arizona

Job Description Summary

Job Description

Position Summary:

This position supports product leadership and risk management of new product development and sustaining activities for combination drug products.

Essential/Key Job Functions:

• Technical leadership skills including an understanding of chemical and pharmaceutical operations (e.g., drug product manufacturing, process development, analytical, quality assurance).

•Leads development of risk assessments and test methods

•Supports component qualifications, design validation / verification and process validation

•Leads product investigations

•Ability to make and present risked based decisions

•Assess product changes against product design

•Supports translation of design inputs into manufacturing control plans

•Develop and implement procedures to comply with corporate and industry standards.

•Coordinates and/or directs all aspects of product development activity related to a product line.

•Leads development of risk assessments and test methods

•Leads and/or support the Product Team on the device aspects of combination products

•Quality engineering representation on Product Development Teams and Design Review Teams.

•Prepare and present project updates and technical discussions.

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

•Support internal and external supplier audits.

•Provide support to the regulatory department in writing technical submissions.

•Complies with company procedures and policies, government regulations.

Skills needed:

•Knows how products are used and impact the user(s) so that risk can be managed effectively.

•Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

•Ability to develop solutions with business impact.

•Advanced statistical and risk assessment techniques.

•Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies.

•Working knowledge of code level review, software logic review, black box testing, and system validation.

•Ability to make and present risk based decisions

•Strong interpersonal skills

•Ability to analyze and optimize manufacturing and quality systems

•Product, design & prototyping

•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 Lead cross functional teams

•Understanding of regulatory requirements including 21 CFR 210, 211, ICH Guidelines, ISO 13485, ISO 14971

•Ability to lead creation of risk management files

Required Qualifications:

•BS Engineering

•1-3 years (Master’s degree plus zero to three years) of engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry.

Preferred Qualifications:

Quality Engineering Certification (ASQ) or equivalent.

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:

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. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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.

#LI-PRO

Primary Work LocationUSA AZ - Tempe Headquarters

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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