Quality Assurance Manager - Manufacturing
Location: Raleigh North Carolina
Description: Technical Staffing Specialists, Inc. is looking of Quality Assurance Manager - Manufacturing right now, this job will be placed in North Carolina. Detailed specification about this job opportunity kindly read the description below. Will serve as a Quality Assurance Manager for a growing organization. The person in this role will develop, implement, and maintain product quality assurance and control systems and activities. Will define and specify the implementation of standards, methods and procedures for investigation and evaluation of complaint process. Will assist manufacturing in gathering and analyzing data to improve process or product quality. Duties include: Develop and administer the company quality programs with regards to goal setting, root cause analysis and corrective and preventive actions. Provide support to Director of Quality Systems and Compliance during audits by regulatory or external and internal agencies. Development of standard operating procedures and product specifications in conjunction with Operations and R&D. Represent Quality in Design Control activities to ensure compliance to quality systems procedures, regulations, and standards. Provide guidance for design and development planning, risk management, and design verification and validation. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Ensure compliance and electrical safety testing is performed to appropriate standards. Identify requirements for verification and validation and reliability testing. Develop product Design History Files (DHR), Technical Files, and Device Master Records (DMR). Partner with Operations, R&D, Marketing and other departments to ensure products are effectively transferred to internal or Contract Manufacturing. Provide quality review process validation and test method validation protocols and reports. Responsible to ensure all documentation reports tests and results meet the requirements of Regulatory Filings and Technical files for CE filings. Provide statistical guidance to test protocols/reports and ensure that the testing is sufficient to meet regulatory requirements and quality objectives. Plan schedule and complete projects in an aggressive sense of urgency manner consistent with corporate objectives. Gather and analyze performance data and tracks against defines goals. Drive corrective and preventive action response through the complaint handling system. Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet specifications. Requirements include: Must be eligible to work in the US without sponsorship Bachelors Degree in Science or Engineering (or related field). CQE certification is desirable. 8+ years of experience in Quality Assurance, Quality Engineering and Management in the medical device industry (or related industry). Experience in related engineering areas, e.g. R&D or Manufacturing is beneficial Knowledge of FDA Quality System Regulation (21 CFR 820) and Medical Device Reporting Regulations (21 CFR 803, 806) and ISO 13485. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables simultaneously. Strong mechanical aptitude and methodical problem solving skills. Strong interpersonal, organizational, and project management skills. Proven self-motivation and leadership skills. Strong oral and technical writing skills. INCLUDE SALARY HISTORY AND REQUIREMENTUSE REFERENCE #081201
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This job starts available on: Fri, 03 Aug 2012 10:50:53 GMT