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Job #03076

About our client Our client is the surgical instrumentation division of a world-leading healthcare company that has developed a reputation for successfully bringing complex products and services to market in a variety of innovative areas. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Quality Assurance Manager San Diego, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee strategic and leadership direction within the QRA function 2) Manage professional employees and/or supervisors 3) Direct business support, technical or production staff 4) Manage financial resources 5) Provide technical guidance to employees 6) Develop processes and procedures to implement functional strategies 7) Apply expertise to improve effectiveness and provide guidance to employees in own area 8) Make decisions, often difficult and/or unpopular, that impact the work of subordinates within the job family and influence subordinates to support decisions by presenting rationale/business case 9) Serve as the role model to demonstrate the company's high ethical standards and code of conduct 10) Recognize development needs and capability gaps in own area and arrange specific projects/assignments to address needs 11) Identify (proactively) talent internally and externally including participation in the succession planning process for job family 12) Cascade organizational goals through the functional/work area to the individual level and ensure that individuals understand how they can contribute 13) Build confidence and respect for others through a positive and energizing style 14) Establish goals and achieve results within own job family and be accountable for results 15) Manage budget for own area and allocate resources accordingly, applying knowledge of profit drivers within own area/job family 16) Interpret internal/external business issues and adapt work priorities in own area 17) Assist in defining strategic plans for own work team/job family or key products/services 18) Work with customers to anticipate and interpret their needs and business challenges 19) Identify quality and service-oriented customer solutions and share key information with others 20) Resolve operational problems that impact the effectiveness of own area 21) Encourage subordinates to strive for operational excellence by continually challenging old methods or ways of thinking and taking calculated risks to maximize results 22) Serve as a role model in innovative thinking and in focusing on quality within work 23) Work collaboratively with internal/external groups to achieve business results, integrating the diverse perspectives of individuals from different backgrounds 24) Coach others in the dynamics of effective teamwork 25) Solicit and explain (effectively) difficult concepts and persuade others to adopt a point of view as well as state own point of view 26) Implement and administer the quality management systems for San Diego's facility operations and serve as a site management representative for quality systems 27) Provide information to establish and maintain regulatory filings including 510(k) submissions 28) Provide quality and reliability plans for engineering projects including the development and implementation of quality specifications, methods and testing protocols 29) Ensure product safety and efficacy and ensure consistency of product quality and service quality. 30) Develop quality plans to support product manufacturing scale-up and transfer activities 31) Report to management on the performance of the FDA-regulated quality system including executing periodic management reviews (as defined in the quality system) 32) Participate in product development teams, providing quality planning and quality system guidance to ensure project success and compliance 33) Interact with external compliance authorities to demonstrate regulatory compliance and product safety and efficacy 34) Recruit, retain, train, develop, manage and lead all quality personnel including inspection, quality technicians, product complaint investigation, calibration, documentation and quality engineering personnel 35) Recommend staffing plan to support product development and manufacturing scale-up activities 36) Participate as a member of facility management to plan and control operations to achieve the Management Agenda established by business unit management to achieve cost, quality, service and innovation initiatives 37) Initiate and implement appropriate corrective and preventive actions related to product or process quality Requirements 1) BA in a Technical/Business or a related field (advanced degree) preferred 2) 2+ years of trained field experience with 5+ years in a supervisory/managerial role 3) 5+ years experience in medical device, regulatory or quality with minimum 3 years in medical device 4) Working knowledge of FDA regulations, quality and document control 5) Understanding of and experience in applying quality system regulations in an R&D environment 6) Professional certification in Quality or achievement within the first 2 years of employment preferred 7) In-depth expertise in own job family and knowledge of the related job families 8) Ability to succeed in a fast-paced and result-oriented culture