Quality Assurance and Regulatory Manager

Manager, Quality Assurance and RegulatoryPosition SummaryThe Quality & Regulatory Affairs Manager provides overall company leadership and direction to meet, create, monitor and improve the quality management systems (QMS) program, keeping the goal of the reduction of quality costs in mind while maintaining compliance within applicable FDA and ISO regulations. Principle ResponsibilitiesMaintain and work towards the continual improvement of the ISO-13485 program and all associated functions including management review, internal and external audits, and associated corrective and preventive actions (CAPAs). Act as the management representative for the Tecomet-OEM Solutions Riviera Beach Quality System with authority and responsibility for: ensuring the quality system is established, implemented and maintained in accordance with International Standard and regulatory requirements. reporting on the performance of the quality system to Tecomet-OEM Solutions Riviera Beach management for review and as a basis for further improvement and maintaining effectiveness of the quality system. ensuring and promoting the awareness of regulatory and customer requirements throughout the organization. Act as Lead Auditor to the QMS Internal Audit program Establish and maintain quality management systems that comply with the FDA 21 CFR guidelines, mainly Part 820. Assist in coaching and training of personnel with the QMS. Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans Assist in process validations as needed Records retention/archives management Maintain a culture where safety, quality, schedule and cost are the main focal points with a continuous improvement mentality Project a positive and professional image of the company and of management to employees at all levels Responsible to handle human resource responsibilities in a fair, consistent, unbiased, confidential and positive manner while abiding by all laws, policies and procedures Responsible for interviewing, providing training, counsel and evaluations, discipline and termination of employees Develop and maintain customer relationships Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs Optimize manufacturing process run time by identifying and eliminating production failures Coach and provide training for Quality Engineers, Six Sigma Green Belts and Quality Inspectors Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans Determine if a potential supplier has the basic systems and machine capabilities in place prior to placing an order with that supplier Develop and administer systems that facilitate the certification of suppliers, subsequently reducing and/or eliminating Tecomet-OEM Solutions Riviera Beach receiving inspection time and cost Participate in the Material Review Board process Follow-up on all internal and external corrective action responses Internal & external audits and supplier approvals Oversee special processes validations Oversee gage control Device pre-sterile packaging and sterilization requirements Maintain a culture where safety, quality, schedule and cost are the main focal points with a continuous improvement mentality Project a positive and professional image of the company and of management to employees at all levels Responsible to handle human resource responsibilities in a fair, consistent, unbiased, confidential and positive manner while abiding by all laws, policies and procedures Responsible for interviewing, providing training, mentoring and evaluations, discipline and termination of employees Qualification RequirementsAssociates Degree or ASQ CQE and/or CQA Certification may be adequate if the experience time is double Three years manufacturing experiences ASQ Certified Quality Auditor or equivalent ISO/FDA Lead Assessor and/or Auditor Experience/Educational/Training PreferredRAB & AMSE Certification preferred Knowledge, Skills, And AbilitiesStrong organizational skills Strong people and leadership skills Diplomacy Motivation Teaching/Coaching/Mentoring Excellent verbal and written communication and listening skills Professional writing skills Problem solving and evaluation Process improvements Computer operation Project management Streamlining processes Self-Motivated Speak in front of people in a variety of settings Be flexible and adapt to changes in the marketplace Create and manage high performing work teams Identify and make process improvements Interface professionally and courteously with customers/public/internal staff Prioritize work Meet goals and objectives set for department and company Keep current in changing work methods and regulatory changes Supervise and manage several projects Make decisions in a consistent, professional manner Maximize opportunities for the business Work EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.