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Director of Quality Control and Regulatory Affairs

Exton, PA
Job Opportunity 
Director of Quality Control and Regulatory Affairs

Compensation Package:        
Base Salary: $100,000 - $170,000      
Bonus Potential: 20% of Base Salary
401k Option: Company also provides a up to matching contribution option                                   
Healthcare Benefit Options: Medical, Dental, Vision, Flexible Spending Account and Dependent Care Insurance: Life and Disability Insurance                         
Paid Time Off: Vacation and Sick paid days off are available
Expense Information: Company pays for all business-related expenses (compliance regulations apply)

This position manages quality and compliance aspects of the US business for our client.  Responsibilities include establishment, further development and maintenance of Quality Management System in compliance with 21 CFR 820 and ISO 13485:2016, communication with regulatory bodies, conducting audits and supporting compliant execution of quality-related processes. Implementation and transfer of the QMS into the organization and ensuring that it is lived in everyday life.   
Key Success Indicators: Quality Management          
  • Assure compliance of processes with 21 CFR 820 Quality System Regulation and ISO 13485:2016 
  • Liaise and coordinate activities with external certification bodies in order to obtain and maintain ISO 13485:2016 certification
  • Ensure critical business and QMS processes are established, implemented and maintained
  • Conduct annual review of company Quality Systems Manual
  • Implement and manage Quality System version and document control
  • Document retention and archiving systems
  • Conduct and coordinate annual internal audits as per predetermined schedule or as required
  • Establish and maintain procedures of process qualification and validation
  • Establish and maintain procedures to control nonconforming products and to prevent mix-ups
  • With department managers, plan and monitor business critical documentation review schedules
  • With department managers, identify and implement internal controls required for business-critical process
  • Identify gaps or non-conformance in business-critical process and work with management to resolve in line with best business practice
  • Review and identify continuous improvements as required within the quality manual and policies and procedures necessary to the quality system
  • Prepare and present report to summarize the result of internal audits, complaints, CAPA/NCR and any opportunities for improvement to management team for review 
  • Report to local Senior management and Head QM/RA (Basel) on performance of the Quality Management System with Regulatory Affairs in respect to product approval for the US
  • Work with Customer Service and Logistics with respect to import requirements of the FDA in order to facilitate importing of products"    
Key Success Indicators: OSHA           
  • Maintain health and safety management system
  • Organize and coordinate quarterly health and safety meetings, take minutes and monitor actions
  • Retain a health and safety schedule; recording annual checks, management and review of incident reports
  • Monitor changes to legislation and implement business wide
  • Conduct health and safety inductions and training for staff, contractors and visitors, as required
  • Conduct facility walk throughs and perform business area risk assessments
  • Implement corrective and/or preventative action on identified potential hazards
  • Maintain accident and incident reporting register"   
  • Bachelor’s Degree in Engineering, Science or related study is preferred   
  • A minimum of ten years’ experience in Medical Devices (5+ years within the Orthopaedic space)
  • A minimum of five years of experience working in a highly-regulated regulatory environment, engineering, quality, or related field
  • Demonstrate experience coordinating Quality Management Systems processes and procedures with the application and implementation of ISO 13485-2016 Medical Device regulations.  Sound knowledge of FDA Quality System Regulations; 21 CFR 820                                                                                                                                                                                                                                    
  • Knowledge and experience with regulatory procedures and legislation for medical development, product registration, line extension and license maintenance.
  • Strong communication, teamwork and problem-solving skills are required. Strong root cause analysis skills are required as well
  • Track record of drafting and submitting regulatory documents and insuring compliance related to quality, manufacturing standards, clinical trials, submission data, etc.  
  • Demonstrated experience with a Oracle and/or SAP system is preferred (e.g. Cebos EQMS)
  • Experience in FDA customs requirements with respect to EU imports is preferred
  • Strong Microsoft Office skills in Word, Excel and Outlook
  • Must complete a successful background check and drug screening           
  • Must have a valid Driver’s License
  • Legally authorized to work permanently in the U.S. and not require sponsorship for employment visa status now or in the future                                                                                                                                                     
Our client is an EO employer – M/F/Veteran/Disability.  "We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."
LEE WEBER GROUP--Placing you in a Better Future
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Office: 859-296-1112
Email: mail@leewebergroup.com
Fax: 859-296-0050
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