ESSENTIAL FUNCTIONS:
- The Senior Quality Engineer, Validation has primary responsibility for driving overall quality performance and compliance throughout the organization.
- Develop and execute IQ, OQ and PQ protocols for product, processes and equipment within the facility.
- Write reports summarizing results and statistics for all equipment, product, or process validation projects.
- Review existing validation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
- Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.
- Participate as an active member in the new products development team.
- Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.
- Conduct or lead corrective and preventive actions in manufacturing using formal problem solving tools and documentation.
- Provide day-to-day support to engineering and manufacturing for design control planning and design transfer activities.
- Develop and execute software validations where necessary.
- Perform other duties as assigned
Job Requirements
QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:
- Experience in the medical device industry in the development
- and deployment of Quality Systems, and process controls, and continuous
- improvement methods.
- 5-7 years in manufacturing/quality assurance engineering experience in and FDA regulated environment.
- Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.
- Knowledge and working application of Validation Principles and guidelines and industry practice.
- Knowledge and working application of FMEA and Risk Analysis.
- Practical experience in product design and development.
- Knowledge and working application of reading and understanding blue prints and technical drawings.
- Knowledge and working application of standard operating procedures.
- Demonstrated strong analytical problem solving (CAPA), teaming and communications/interpersonal.
- Desired CQE, CSSBB, CQA or initiative to complete
- certifications. Ø Internal Quality System auditing experience (ISO 13485
- and FDA 21CFR820).
- Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
- Ability to multi-task and methodically manage projects.
- Ability to: stand or walk for long periods, lift and carry at least 20 pounds, perform repetitive motions with hands/fingers.
EDUCATION/EXPERIENCE REQUIRED:
- Bachelors of Science in Engineering or other related technical field.
- PHYSICAL DEMANDS:
- Able to exert up to 10 pounds of force occasionally
- Able to sit most of the time.
WORK ENVIRONMENT:
- General office environment
- Adequate lighting and temperature.
- No hazards or unpleasant conditions caused by dust, etc.
