Posted in Health Care 30+ days ago.
JOB DUTIES AND RESPONSIBILITES:
Serve as management representative for Novo Health Services with the authority to ensure that the requirements of 21 CFR 820 is effectively established, implemented and maintained.
Support the development and implementation of quality improvement interventions and audits and assist 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.
Incorporate 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 Synergy Health 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.
Design work flows and procedures; generate creative solutions; use feedback to modify process designs; apply design principles and demonstrates attention to detail.
Analyze data to identify process improvement initiatives.
Act 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.
Work with customers in both the conversion to the compatible reprocessing methods and required compliance requirements.
Maintain 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.
Work with sales personnel in the evaluation of potential customer cycles for the purpose of providing information for quotes and customer related quality matters.
Assist 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.
Create detailed and accurate project tasks and schedules, while interfacing with project team members and other support personnel; solving project-related conflicts and issues.
Assist with new and existing supplier evaluation and approval process.
Act as the Voice of Quality importance on cross functional teams.
Perform other duties and projects as assigned.
Normal work conditions will vary and will include exposure to office and sterile processing department. Must be willing and able to wear and use personal protective equipment (PPE) appropriate to the work environment. PPE may include gloves, liquid proof gowns, and face protection. This list is not all inclusive.
Travel required up to 10% of time.
EXPERIENCE, KNOWLEDGE, AND SKILL REQUIREMENTS:
At least 3 years of experience in a QA position, preferably in the medical device manufacturing industry, and/or experience working in a quality and compliance role in other regulated industries.
Strong understanding of medical devices quality system regulations, problem solving skills, data analytic skills, and risk management are essential for this role.
Self-starter who has experience with total quality management systems, 21 CFR Part 820 regulations, lean systems and continuous improvement methods.
Working knowledge of MS Word and Excel - able to develop forms, tables and spreadsheets
Excellent communication skills (both verbal and written)
Attention to detail and highly organized- Able to multi-task and prioritize
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.
Proficient in Microsoft Office
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:
High School Diploma or GED required.
PHYSICAL REQUIREMENTS: (List specifics of required lifting, carrying, standing, climbing, and movement activities.) ADA: NOVO Health Services will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990 and its amendments.
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