Creganna-Tactx Medical is leading supplier of products, technologies and services to medical device manufacturers worldwide. The company is ranked among the Top 10 medical device outsourcing companies in the world and serves over 400 customers in 30 countries. We are respected partners to the industry’s leading brands for Minimally Invasive therapies and command a market leadership position in key segments. A lifesaving medical device containing our technology is used every 1.2 seconds.
Working in a fast-paced environment, we are defined by a shared set of values – to be reliable, honest, flexible and innovative in everything we do. Our company story is about growth and our team is the backbone of our success. The shared stories of our people are about development opportunities in this growth environment and about the millions of people around the world that lead healthier lives because of our life’s work.
Creganna-Tactx Medical is seeking an innovative, knowledgeable and highly versatile Sr. Quality Engineer. The right candidate will be able to adapt quickly to changing priorities and manage multiple projects simultaneously while ensuring that every product and service we supply conforms to FDA QSR, ISO 13485 and MDD standards.
The Senior Quality Engineer (SQE) will work as part of a core team supporting production and new product introduction activities. The SQE will create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards. He/She will liaise with customers to align product specifications, manufacturing procedures, test methods, and acceptance criteria. The SQE will ensure that products satisfy customer needs through design control activities, process validation, risk management, and the use of statistical methods.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Participate as a key member of new product development to ensure quality plans, specifications, manufacturing/test procedures, risk and validation documentation are established.
- Participate in design control activities, including design reviews
- Evaluate processes and technologies for reliability, capability, consistency and cost effectiveness
- Design and develop instructions and forms for recording, evaluating, and reporting quality data
- Independently design and execute experiments; utilize DOE to determine sources of variation in products and processes
- Develop validation protocols for manufacturing equipment and processes; evaluate data and write reports
- Assist in design transfer activities of new products
- Interface with suppliers to improve or resolve quality issues
- Identify and implement improvements to promote product quality and manufacturability
- Bachelor's Degree with a scientific emphasis required
- Demonstrated technical proficiency, independent thought and collaboration with others
- Minimum 5 years experience in an FDA-regulated industry; 8+ years preferred, with 5+ years in Quality
- Experience in design control, validation, protocol writing and risk management
- Expertise in statistical and analytical techniques, measurement tools and process design
- Ability to read and interpret drawings and design specifications
- Excellent technical writing skills and verbal communication
- ASQ certified Quality Engineer preferred