Quality Assurance and Regulatory Manager

Manager, Quality Assurance and Regulatory

Position Summary

The 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 Responsibilities

• Maintain 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 Requirements

Credentials/Experience:

• Associates 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 Preferred:

• RAB & AMSE Certification preferred

Knowledge, Skills, and Abilities:

• Strong 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

Other Requirements

Work Environment

The 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.

Physical Requirements

The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear.  The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl.   The employee could occasionally lift and or move up to 50 pounds.  Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.

Travel Requirements

Up to 10%

Americans with Disabilities Act (ADA):  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified.  Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.

Equal Opportunity / Affirmative Action Employer / Protected Veterans / Disabilities/Drug Free Workplace

Tecomet, Inc is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, gender identity, religion, sexual orientation, national origin, disability, genetic information, pregnancy, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.