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Senior Quality Assurance Engineer
Closing Date: July 30, 2012
| Company: | CIVCO Medical Solutions
Kalona, IA |
| Job Location: |
Orange City - Sioux County
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| Employment Type: | Full Time |
| Department: | Quality/Regulatory - OC |
| Benefits: | Competitive pay and benefits including: paid time off, health/dental/vision insurance, 401k, flexible spending plan, and paid holidays |
Description: | 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 Orange City, 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.
The Senior Quality Assurance Engineer will be responsible for improvement projects in quality, engineering, and production systems. Assist product development and design control, providing manufacturing support, and driving continuous process improvement. | Duties: | * 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, "Member of 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 and document manufacturing tools such as templates.
* Support documentation/implementation for CIVCO Quality Systems to ensure with company, customer, FDA/GMP, ISO 13485:2003, MDD standards requirements.
* Ensure compliance with company, customer, US and international regulatory requirements/standards (FDA, European Medical Device Directive - MDD, Japan MHW, Canada MDR) regarding design, manufacture, and sale of medical devices.
* Support engineering, production, and customer - to identify quality program requirements, develop product specifications, prepare quality plans/objectives for finished products; design review.
* Assist in preparing, submitting and maintaining documentation for US and international regulatory agency market approvals (510(k)); PMA; Device Listings; CE Marking; MHW)
* Serve as a point-of-contact with FDA, MHW, and other regulatory agencies.
* Support FDA Medical Device Reporting (MDR) and MDD/Canadian Vigilance System.
* Investigate/resolve quality-related non-conforming materials/components and in-process, and customer complaints (COMs); provide statistical trend analysis for COMs.
* Provide engineering support documentation - specifications; technical file; Essential Requirements; risk analysis; labeling; instructions.
* Represent RAQA in product design review/release process.
* Support, design, perform, and report product validations.
* Develop and implement methods and procedures for inspection, testing, and evaluation.
*Take corrective action on deficiencies within Quality area.
*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.
* Take corrective action on deficiencies within production area, including purchasing.
* Identify and execute projects to improve package, label, instruction, and kit design.
* Carry out special systems improvements projects as needed.
* Keep up-to-date on current developments in profession. | Qualifications: | The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
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. |
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