BD (Tissuemed Ltd)
Sr. Quality Engineer - CAPA
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BD (Tissuemed Ltd)
Job Overview 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.
Responsibilities
Manage the intake of issues through the CAPA Program
Support the CAPA initiator with technical writing of the Problem Statement, Containment Plan, and CAPA Determination decisions.
Support the risk management team to perform risk assessments for product‑related CAPAs in a timely manner.
Work with cross‑functional leaders to identify appropriate CAPA Owner in a timely manner.
Initiate CAPA records in TrackWise once all required fields are gathered.
Work with the CAPA Owner to develop an Investigation Plan and Targeted Duration Request for the Investigation phase, as needed.
Ensure all CAPA records are approved within the required 14‑day timeframe.
Support CAPAs in the Investigation and Planning phases as needed.
Qualifications
Bachelor’s degree in Engineering or Science
Experience in the medical device industry required
Minimum 5 years experience in a 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
Location Primary Work Location: USA, CA - San Diego TC Bldg C&D. Remote or field‑based positions may be considered depending on the business needs.
Compensation $102,000.00 - $168,200.00 USD Annual
EEO Statement 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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at
BD (Tissuemed Ltd)
Job Overview 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.
Responsibilities
Manage the intake of issues through the CAPA Program
Support the CAPA initiator with technical writing of the Problem Statement, Containment Plan, and CAPA Determination decisions.
Support the risk management team to perform risk assessments for product‑related CAPAs in a timely manner.
Work with cross‑functional leaders to identify appropriate CAPA Owner in a timely manner.
Initiate CAPA records in TrackWise once all required fields are gathered.
Work with the CAPA Owner to develop an Investigation Plan and Targeted Duration Request for the Investigation phase, as needed.
Ensure all CAPA records are approved within the required 14‑day timeframe.
Support CAPAs in the Investigation and Planning phases as needed.
Qualifications
Bachelor’s degree in Engineering or Science
Experience in the medical device industry required
Minimum 5 years experience in a 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
Location Primary Work Location: USA, CA - San Diego TC Bldg C&D. Remote or field‑based positions may be considered depending on the business needs.
Compensation $102,000.00 - $168,200.00 USD Annual
EEO Statement 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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