Quality Manager is an independent self-starter who has experience with total quality management systems, 21 CFR Part 820 regulations, lean systems and continuous improvement methods. This position is responsible for implementation and managing of continuous improvement projects, regulatory compliance, implementation of business and quality initiatives, while working directly with all SRI Healthcare stakeholders and its customers. Strong understanding of medical devices quality system regulations, problem solving skills, data analytic skills, and risk management are essential for this role.
Serve as management representative for the company with the authority to ensure that the requirements of 21 CFR 820 are effectively established, implemented and maintained.
Supports the development and implementation of quality improvement interventions and audits and assists in resolving deficiencies impacting compliance to regulatory and accreditation standard.
Ensure the requirements of all regulated processes are satisfied and that the appropriate documentation is maintained.
Incorporates FDA, ASTM, ISO standards/regulations throughout the product life cycle, while developing the required inspection and process control methodologies.
Manage GMP, blood borne pathogen program and other training programs as required/assigned.
Maintain the facility internal audit program. Conduct periodic internal audits of SRI Healthcare facilities to gauge the level of compliance and to implement corrective actions where applicable.
Identify, document and report potential compliance issues affecting the company’s products, related processes, and the quality system.
Organize and conduct Quality System Management Reviews.
Designs work flows and procedures; generates creative solutions; use feedback to modify process designs; applies design principles and demonstrates attention to detail.
Analyze data to identify process improvement initiatives.
Acts as a subject matter expert resource to lead and/or participate in the investigation and remedial action identification for non conformances, customer complaints, etc. Drafts technical responses for communications to customers or regulatory agencies.
Works with customers in both the conversion to the compatible reprocessing methods and required compliance requirements.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional society’s activities; etc.
Works with sales personnel in the evaluation of potential customer cycles for the purpose of providing information for quotes and customer related quality matters.
Assists as a technical resource for service centers to improve processing efficiencies, correct identified facility deficiencies, and solve “problematic” issues beyond the scope of local service centers to support continuous improvement.
Creates detailed and accurate project tasks and schedules, while interfacing with project team members and other support personnel; solving project-related conflicts and issues.
Assists with new and existing Supplier evaluation and approval process.
Acts as the Voice of Quality importance on cross functional teams.
Other duties as assigned.
At least 5 years of substantial experience in medical device industry, including a broad range of experience within the sterilization and medical device reprocessing that includes management, operational and quality experience. Additional training or experience in auditing, project management, problem-solving, and statistics is desirable.
Bachelor Degree in Science, Healthcare, or related field is required.
KNOWLEDGE, SKILLS, ABILITIES:
Ability to effectively communicate with employees, customers, vendors, government agencies, community groups and others.
Knowledge of the structure and content of the English language including meaning and spelling of words, rules of composition and grammar.
Strong technical writing skills and ability to create technical protocols and reports.
Advanced mathematical skills required with experience in statistical data.
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.