5 years quality experience in medical device industry
Strong technical writing skills required
Experience managing quality improvement projects
The Sr. Quality Engineer is responsible for coordinating the implementation of key business process improvements and gap assessments for BD MMS products
Job Summary
The Sr. Quality Engineer is responsible for coordinating the implementation of key business process improvements and gap assessments for BD MMS products.
This role requires ensuring that business processes meet regulatory and corporate requirements such as ISO 14971, 13485, 9001, and FDA QMSR.
Candidates must possess a BS or MS in a technical field with specific years of experience in Quality, Risk Management, and Design Controls within the medical device industry.
Matching Summary
The Sr. Quality Engineer is responsible for coordinating the implementation of key business process improvements and gap assessments for BD MMS products.
Salary
Base: $102,000.00 - $168,200.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package including well-being and development rewards
Skills & Requirements
Must-have
5 years Quality experience in medical device industry
Strong technical writing skills required
Experience managing quality improvement projects
Knowledge of ISO 14971 and ISO 13485 standards
Understanding of FDA QMSR requirements
Nice-to-have
Non-product software validation experience
Infusion pump product experience
Ability to work independently with high initiative
Cross-functional collaboration skills
Training facilitation capabilities
Key Requirements
BS in technical field with 5 years experience OR MS with 3 years
Required experience in Quality, Risk Management, and Design Controls