A medical device manufacturing client is looking to hire a new senior quality engineer for their catheter division of business! This Sr. Catheter Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on providing quality engineering support to the new product development process, operations/production, and quality systems. This individual will also serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities.
Key Responsibilities:
- Provide Quality Engineering support for engineering product development and sustained manufacturing of catheters
- Ensure quality requirements are communicated and met at suppliers
- Review manufacturing records to perform lot release activity for catheters, including COC issuance
- Provide Quality Project Management support as needed for product transfers from development to validation to production.
- Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.
Must Have:
- Bachelor of Science, preferably in biomedical, mechanical, or materials engineering
- 5-8 years of experience as a quality professional in the medical device industry
- Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
- Must possess excellent verbal communication, organizational and management skills.
- Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement
- Minitab experience desirable.
- Catheter experience preferred.
The pay range for this role is $115,000 to $166,000 + Bonus
