SENIOR QUALITY ASSURANCE ENGINEER
JOIN OUR TEAM & MAKE A DIFFERENCE!
Title: SENIOR QUALITY ASSURANCE ENGINEER
Date Opened: August, 2009
Location: KALONA, IA
CIVCO Medical Solutions' growth has created a new opportunity for a Senior Quality Assurance Engineer in one of our state of the art manufacturing facilities based in Kalona, Iowa. CIVCO is a global leader in the design, manufacture, and marketing of specialized medical products used in several business segments including minimally invasive diagnostic and therapeutic procedures, ultrasound and urology, and radiation oncology.
Position Summary
The Senior Quality Assurance Engineer will be responsible for improvement projects in quality, engineering, and production systems as well as assisting in product development and design control, providing manufacturing support, and driving continuous process improvement.
Essential Duties and Responsibilities
- Build on our customer-focused values by constructing an environment where the highest level of quality and customer service is priority to all associates.
- Review change orders; participate on Material Review Board; review first articles; write, coordinate and perform equipment IQOQ PQ's; write, review, or perform product design verification validations; review risk analysis; create or update engineering drawings, create & document manufacturing tools such as templates.
- Support documentation and implementation of CIVCO Quality Systems to ensure compliance with Company, Customer, FDA/GMP, ISO 13485, EN46001 standards.
- Provide engineering, production, and customer support by participating in design review, identifying quality program requirements, developing product specifications, and preparing risk analysis and quality plans/objectives for finished product.
- Investigate and resolve quality-related issues while maintaining statistical trend analysis.
- Develop and implement methods and procedures for inspection, testing, and evaluation.
- Create quality-related corrective action plans and implement.
- Design, perform, and report process validations.
- Review and audit product structures, drawings and database for accuracy and completeness.
- Support measurement of productivity and maintenance of standard target rates for production processes.
- Participate in supplier evaluations/on-site audits.
- Execute special systems improvement projects as needed.
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accomodation may be made to enable individuals with disabilities to perform the essential functions.
Education & Experience
Bachelor of Science in Industrial Engineering or a related field from a four-year college or university is preferred with five to seven years of related experience and/or training; or an equivalent combination of education and experience.
Skills & Abilities
Must be able to understand and interpret mechanical drawings with geometric tolerances, be proficient in MS Office, have the ability to problem solve and work independently, and have good communication and organizational skills.
CIVCO offers competitive pay and benefits including: paid time off, health/dental/vision insurance, 401(k), flexible spending plan, and paid holidays.
If personal growth and the opportunity to make a positive impact with a leading company interest you, please send your resume to hr@civco.com.
APPLY TODAY!
CIVCO Medical Solutions
102 First Street South
Kalona, IA 52247-9589
For consideration, access our Online Response Form.
Affirmative Action / Equal Opportunity Employer!
