This is Girish, - Recruitment and Resources from SancroSoft USA Inc.
We have an urgent requirement as follows:
Please respond with resumes in MS-Word Format with the following details to Girish@sancrosoftusa.com
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Senior Quality Engineer with Manufacturing Exp (Medical)
Location: Minneapolis, MN
Duration: long term
YEARS OF EXPERIENCE:
5+ years engineering experience adjustable with increased education, or previous experience in a quality position in a regulated environment
POSITION DESCRIPTION
· Develop and assess the quality programs and systems of Medical Implantable Devices manufacturing company.
· Assure the timely, accurate and independent evaluation of product performance and compliance to safety and regulatory requirements prior to clinical studies or market release.
Provide support for released product, evaluate product field performance and reliability, recommend corrective action, and plan for continuous improvement.
· May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, supplier management and/or product sterilization and biocompatibility as they apply to quality control.
POSITION RESPONSIBILITIES
· Follow all Quality System Practices as defined by organisations practices, policies and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
· Actively participate in product development cycle to ensure Quality issues are addressed and resolved prior to release. Work closely with R&D to develop appropriate qualifications, validations, inspection plans and gauging including reliability assessment for both new design and changes to released product. Assure the resolution of all issues raised by the testing.
· Assess, provide recommendations, and lead implementation of systems, processes and equipment for improvement and compliance to Good Manufacturing Practices within the R&D, Operations and QA/RA processes to ensure safe and effective products are produced. Provide written reports and supporting documentation for recommendations.
Lead problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices.
· Perform machine and process capability and performance studies; recommend and upon approval implement changes and upgrades to systems, procedures or processes to improve product quality.
· Lead complaint investigations; document findings and provide reports and analysis. Recommend and implement corrective action and appropriate follow-up when necessary.
Ensure documentation and findings are completed in a timely manner and in compliance with FDA and European Regulatory agency standards and procedures; recommend and implement actions or changes to improve quality.
· Assist in the development and assessment of customer’s Supplier Program; address problems and recommend solutions to supplier quality; interface as necessary to ensure product specifications are met at supplier; lead supplier audits / assessments.
· Effect continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen.
· Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Train staff, QA inspectors and others as directed to understand specifications, new product audits, procedures, environmental controls, etc.
BASIC QUALIFICATIONS:
EDUCATION REQUIRED:
BS/ MS in Engineering or a related field; 3+ yrs with a MS;
Thanks & Regards,
Girish
The power of focus
SancroSoft USA INC
4944 Sunrise Blvd, Suite B-4 || Fair Oaks, CA 95628
Phone : 916-671-5591|| Fax: 916-200-0305
E-Mail : girish@sancrosoftusa.com www.sancrosoftusa.com
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