| Company: | CIVCO Medical Solutions
Kalona, IA |
| Job Location: |
Kalona - Washington County
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| Employment Type: | Full Time |
| Department: | Quality Engineering - Kalona |
| Benefits: | Competitive pay and benefits including: paid time off, medical/dental/vision/life/disability, 401k, flexible spending plan, and paid holidays |
Description: |
When medical OEM’s need a partner to enhance their product’s performance in precision and accuracy CIVCO Medical Solutions is the answer for improved patient outcomes. Over 30 years CIVCO has built a reputation of innovation and reliability unparalleled in the medical device industry. Today we design and manufacture medical products distributed in 80 countries worldwide, enhancing patient outcomes through advanced guidance and positioning systems, and infection control products.
CIVCO associates are the key to our performance – proud of the contribution they make in patient safety and the effectiveness of medical treatments. Our people work in an environment of mutual respect and professionalism, focusing their efforts on exceptional quality, making a difference every day in the lives of people throughout the world.
At CIVCO, the successful candidate will join the Quality organization to support our growing portfolio of products. This role will involve working with Product Development, Manufacturing, Regulatory and Customer Service insuring that CIVCO’s products and processes are of the highest quality. Excellent communication skills, strong technical problem solving skills and a high sense of urgency are all key factors to be successful in this role.
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Duties: |
Responsibilities of the Quality Assurance Engineer.
• Writes, reviews and executes product design verification & validations’
• Part of team that reviews product and process risk analysis’s
• Support engineering, production, and customer - to identify quality program requirements, develop product specifications, prepare quality plans/objectives for finished products; design review.
• Investigate/resolve quality-related non-conforming materials/components and in-process, and customer complaints (COMs); provides statistical trend analysis for COMs.
• Develop and implements methods and procedures for inspection, testing, and evaluation.
• Identify and execute methods/productivity improvement projects.
• 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.
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Qualifications: |
The preferred candidate will have a BS Degree in Engineering or a related field. 3-5 years experience in a Quality Assurance role is required. Some experience working in an ISO13485 and/or FDA regulated environment would be considered a plus.
The following skills and abilities are critical for job success:
• Understand and interpret mechanical drawings with geometric tolerances.
• Strong problem solving skills and ability to work independently
• Excellent written and verbal communication skills
• Strong organizational skills and attention to detail
• Preference given to someone experience working with ISO9000, ISO13485 Quality Systems
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