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US-TX- Austin-Divisional Vice President Quality Serve as the management representative for Quality functions; determines and implements the quality policies and strategies for the division. Ensures through Quality Assurance and Quality Systems that all quality goals are met, and all policies, practices, and procedures comply with any applicable regulations Maintains an organizational structure capable of meeting both the immediate and long-term objectives of the division. Responsible for implementing and maintaining the effectiveness of the quality system. Responsible for the development and implementation of the Division quality strategy. Ensures that steps are being taken so that the long-term strategy is implemented, and that the division continues to produce the highest quality, safe and effective products that are competitive in the marketplace. Ensures that development activities are in place to maintain a constant supply of talent to meet the challenges of the organization. Leads the quality efforts of the division in support of our business objectives. Ensures through others that policies and practices have the desired effect of a consistent level of quality and compliance throughout the development, manufacturing and distribution of Medical Device products. Establishes policies and procedures to meet those objectives, and puts in place an organizational structure that meets the needs of the organization. Monitors cost and ensures that quality considerations are met at a minimum of increased cost. Minimizes rework or recall through effective, proactive quality involvement in all phases of the product life cycle. Audits activities to ensure compliance and that sound quality principles are built in throughout the organization. Monitors quality data proactively and identifies trends to address and resolve product quality issues, and ensures corrective and preventive actions are taken. Specifically, oversees required improvements in the areas of design controls; complaints and corrective actions; product actions; and supplier quality. As a member of the senior management staff, represents Quality on the management team. Advises Division president and rest of team on all issues pertaining to Quality. Participates in setting strategic direction for the division as a whole. Works closely with R&D, Regulatory, Finance and Sales &Marketing teams to ensure overall goals are met. Leads management review process. Overall responsibility for interaction with FDA and other regulatory bodies for the Division. Overall responsibility for ensuring that the Division complies with applicable laws and regulations For consideration: meddevice@westcoaststaffing.com
US-CA-San Diego Quality Control Services Manager DUTIES & RESPONSIBILITIES · Responsible for the Receiving Inspection and Calibrations departments. Provides services to support Manufacturing Operations to satisfy the customer demand and Lean initiatives. · Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams. · Develops, implements and maintain scorecards for responsible teams functions (QS Subsystems). Identifies areas requiring quality improvement through tracking and trending. Initiates and follows through on action plans necessary for implementation. . This position manages: Receiving Inspection function, Final and DHR Final Review, Calibrations Department, and Line Auditing Function. · Responsible for overseeing the Line Auditing function in accordance with QA system requirements. · Drive and promote compliance with the QA System, as it relates to responsible functions as well as the rest of the QA System. · Accountable for review process of NCMRs to verify discrepancy and adequacy of response to corrective action request. Dispositions NCMRs. · Responsible for team building, identifying resource gaps, and developing personnel development plans to enhance the capabilities of the department. Education and Qualifications: · Bachelor’s degree in technical field and 8 to 10 years of experience is required; or equivalent combination of education and experience. · Managerial experience in one or more of the following: quality, engineering, manufacturing operations or technical customer service and support.
· Direct experience with medical devices, and regulatory environments (i.e. GMPs, ISO9001, EN46001, etc.) required. · Must be able to apply GMP principles to the production and process controls sub-systems. · Must have knowledge of Quality Engineering discipline, including statistics. ASQ Certified Quality Engineer preferred. · Strong Quality Auditing principles. · Strong working knowledge of DMAIC \Six Sigma problem solving process. Belt certified a big plus · Proven track record of initiating and driving continuous improvements. for considerations please reply to: meddevice@westcoaststaffing.com
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