Job Opening for Quality Manager in Novo Health Services (1416 Dogwood Way, Mebane, NC 27302)

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Job Category : Management
Company Name: Novo Health Services
Position Name: Quality Manager
Location : 1416 Dogwood Way, Mebane, NC 27302
Job Description : MAJOR PURPOSE OF THIS JOB: Primary responsibility for the management and maintenance of the Quality and Regulatory Systems at SRI Healthcare processing facilities. Key member of the facility management team. This position will help improve overall customer satisfaction through specified improvement projects.JOB DUTIES AND RESPONSIBILITES: · Manage the total quality program, policies and initiatives. Ensure compliance with established quality and regulatory programs to meet FDA and other regulatory guidelines.· Guide and direct Quality Assurance Technicians, conduct employee performance reviews and recommend wage adjustments.· Serve as the facility Management Representative with the regulatory authorities.· Perform final quality assurance review and release of all products manufactured, assembled, and/or distributed by the facility.· Maintain the facility internal quality audit program to gauge the level of compliance to established policies and procedures. Assist with Corporate audits of other SRI Healthcare facilities as requested.· Maintain the Product Complaint System at the facility level. Responsible for researching complaints, developing a corrective action plan in conjunction with facility management, implementing the plan and communicating corrective action responses to customers.· Maintain the facility Non-Conformance and CAPA system and appropriate documentation.· Participates as part of the facility management team to identify document and investigate non-conformance issues at the facility, ensuring that appropriate corrective measures are implemented and monitored.· Provide support to the Operations, Sales and Engineering Teams to ensure plant and customer issues are addressed and resolved in a timely manner.· Support the development and implementation of quality improvement projects and goals.· Ensure the requirements of all regulated processes are satisfied and the appropriate documentation is maintained.· Manage the GMP, GDP and blood borne pathogen programs and other training programs as required/assigned.· Identify, document and report potential compliance issues affecting the company’s products, related processes, and the quality system.· Act as the subject matter expert resource to lead and/or participate in the investigation and remedial action identification for nonconformances, customer complaints, etc.· Assist with new and existing supplier evaluation/auditing and approval process as requested.· Acts as the Voice of Quality importance on cross functional teams.· Perform other duties and projects as assigned.WORKING CONDITIONS: · This is a combination of office, plant and customer-based environments.· Travel required up to 20% of time.EXPEREINCE, KNOWLEDGE, AND SKILL REQUIREMENTS: (List the minimum requirements for the position.)· At least 2 years of experience in the medical device industry. Experience within the sterilization and medical device reprocessing is preferred.· 2 years of experience to include management, operational and quality initiatives is desirable.· Experience in auditing, project management, problem-solving, root cause analysis and statistics.· Independent self-starter, team player, ability to set priorities, be flexible, multi-task and meet deadlines.· Experience with at least one of the following systems preferred: total quality management systems, FDA Quality Management Systems (21 CFR Part 820), lean systems, continuous improvement methods.· Ability to effectively communicate with employees, customers, vendors, government agencies, and others.· Technical writing skills with the ability to understand and implement technical protocols and assist with reports.· Good mathematical skills required with experience in statistical data preferred.· Committed and accountable to achieving team goals, Abide by team decisions.· Use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems, while demonstrating attention to detail.· Sets and achieves challenging goals and is persistent to overcome obstacles.EDUCATION AND TRAINING REQUIREMENTS: (List the minimum requirements for the position.)· Bachelor Degree (Science, Health, or related field is preferred). Experience in medical device, pharmaceutical, food/beverage or other regulated industries may be considered a substitute for education.Job Type: Full-timePay: From $55,000.00 per yearBenefits:401(k)401(k) matchingDental insuranceFlexible spending accountHealth insuranceHealth savings accountLife insurancePaid time offReferral programRetirement planVision insuranceSchedule:8 hour shiftDay shiftMonday to FridayOn callOvertimeSupplemental Pay:Signing bonusAbility to commute/relocate:Mebane, NC 27302: Reliably commute or planning to relocate before starting work (Preferred)Experience:medical device industry: 2 years (Preferred)Work Location: One location
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