BD
Job Description Summary
The Senior Quality Engineer will support the implementation of the CAPA system for the Infusion MMS business unit, in accordance with QMS policies and procedures. This role supports the development and maintenance of the CAPA process to ensure corrective actions are timely and effective according to established requirements.
Company Overview We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities
Manage the intake of issues through the CAPA Program
Supports the CAPA initiator with technical writing of the Problem Statement, Containment Plan, and CAPA Determination decisions.
Supports risk management team to perform risk assessments for product related CAPAs in a timely manner.
Works with cross-functional leaders to identify appropriate CAPA Owner in a timely manner.
Initiates CAPA records in TrackWise once all required fields are gathered.
Works with CAPA Owner to develop an Investigation Plan and Targeted Duration Request for the Investigation phase, as needed.
Ensures all CAPA records are approved within the required 14-day timeframe.
Supports CAPAs in Investigation phase and Planning phase as needed.
Qualifications
Bachelor’s degree in Engineering or Science
Experience in medical device industry required
Minimum 5 years experience in technical Quality Engineering capacity
Knowledge of FDA regulations and ISO standards excellent communication skills, both written and verbal
Ability to work independently and collaboratively as part of a team
Strong analytical and problem-solving abilities
Proficiency in Microsoft Office Suite
Salary Range:
$102,000.00 - $168,200.00 USD Annual
Location:
USA CA - San Diego TC Bldg C&D
Equal Employment Opportunity:
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
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Company Overview We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities
Manage the intake of issues through the CAPA Program
Supports the CAPA initiator with technical writing of the Problem Statement, Containment Plan, and CAPA Determination decisions.
Supports risk management team to perform risk assessments for product related CAPAs in a timely manner.
Works with cross-functional leaders to identify appropriate CAPA Owner in a timely manner.
Initiates CAPA records in TrackWise once all required fields are gathered.
Works with CAPA Owner to develop an Investigation Plan and Targeted Duration Request for the Investigation phase, as needed.
Ensures all CAPA records are approved within the required 14-day timeframe.
Supports CAPAs in Investigation phase and Planning phase as needed.
Qualifications
Bachelor’s degree in Engineering or Science
Experience in medical device industry required
Minimum 5 years experience in technical Quality Engineering capacity
Knowledge of FDA regulations and ISO standards excellent communication skills, both written and verbal
Ability to work independently and collaboratively as part of a team
Strong analytical and problem-solving abilities
Proficiency in Microsoft Office Suite
Salary Range:
$102,000.00 - $168,200.00 USD Annual
Location:
USA CA - San Diego TC Bldg C&D
Equal Employment Opportunity:
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
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