Quality Assurance & Regulatory Affairs Manager

Company: Ivoclar Vivadent
Location: Seattle
Posted on: May 27, 2023

Job Description:

Overview
Quality Assurance & Regulatory Affairs Manager
Create smiles for our global customers! Join the Sagemax production team producing dental zirconia discs and products used in dental restorations.
Join our Quality and Regulatory Assurance team. Maintain the Company's quality management system and managing its regulatory compliance activities to ensure that the company complies with relevant national and internal regulations and standards.
What does Sagemax do---
Sagemax is one of the world's leading dental manufacturers and suppliers of zirconia. Founded in 2006, the company is a rapidly growing provider of aesthetic zirconia products for leading dental CAD / CAM systems.
What do we offer...

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  Vacation & Sick leave -
  
  
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  Medical, Dental, and Vision insurance
  
  
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  We provide both PPO & HDHP options for medical
  
  
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  Dental insurance is free to all employees
  
  
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  Option of Flexible Spending Accounts
  
  
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  Life insurance & 401(k) retirement plan
  
  
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  Employer 401(k) contributions after one year of work
  
  
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  Employee incentive programs
  
  
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  Employee referral program with a bonus of $1,500
  
  
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  Full benefits package to full-time employees after a month of work
  
  
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  Employee incentive programs
  
  
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  Fitness reimbursement program
  
  
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  Tuition reimbursement program
  
  
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  Company events and monthly birthday lunches
  
  
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  Free snacks, unlimited coffee, hot coca, water, and teas.
  
  
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  Annual reviews with potential raise, and bonus
  
  
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  Discounts on Verizon phone plans, Microsoft Office, and more!
  
  
  Enjoy task variety
  In our small and dynamic team, you will be provided a wide range of trainings and development opportunities.
  Space to grow
  Plenty of room for your own ideas. Space to try, fail and learn!
  Attractive location
  The Sagemax office, located in Federal Way, WA in between Seattle and Tacoma. The perfect surroundings for your everyday work life are waiting for you.
  Equal Opportunity Clause
  Sagemax is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Race/Color/Gender/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Veteran.
  Sagemax embraces diversity in every aspect - it doesn -t matter where you come from or how you identify yourself.
  Reasonable Accommodation Statement
  Sagemax is committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. Sagemax is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act (ADA).
  Responsibilities
  Responsibilites:
  
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    Plan and evaluate changes/quality process improvements in collaboration with process owners and follow- up on their implementation.
    
    
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    Analyze data from core processes, periodic reporting, organizing management review, and participating in the quality planning processes.
    
    
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    Plan, direct, and coordinate QC Laboratory operations including product inspection, testing, maintenance of quality control test methods, product release specifications, maintenance of the laboratory information system, and adequacy of laboratory test equipment.
    
    
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    Liaise with parent corporation to promote global QMS planning and harmonization.
    
    
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    Manage all regulatory product registrations/510K applications in the USA. Participate and assist in international product registration process.
    
    
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    Manage and maintain all regulatory certifications as applicable including ISO 13485, MDD 93/42/ECC, MDR 2017/745, MDSAP, FDA/Health Canada Establishment registrations for all products as appropriate.
    
    
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    Serve as primary company contact for all regulatory inspections/audits concerning medical devices, safety, & hazardous materials.
    
    
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    Manage all Adverse Event Reporting in appropriate jurisdictions and maintain all records as required.
    
    
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    Manage and oversee the Product Recall Process and maintain all records as required.
    
    
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    Participate in Design Control process as Quality representative. Assist with compilation and maintenance of Design History Files.
    
    
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    Manage quality systems document handling and maintenance activities, including electronic data management, QUMAS system and the specification management process. Coordinate LMS activities as they pertain to regulatory training defined in the QUMAS system.
    
    
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    Facilitate and manage various aspects of change control process including the design transfer process.
    
    
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    Review and approve future processes for change control by evaluating effects of change and ensuring internal processes are considered.
    
    
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    Manage the non-conformity, CAPA, and audit programs.
    
    
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    Work with management to implement and maintain appropriate supplier controls to assure expectations as to quality and business performance.
    
    
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    Manage, coach, and mentor department employees and conduct regular performance reviews.
    
    
    Qualifications
    Must-haves:
    
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      Bachelor's degree
      
      
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      5 years of experience in quality for a medical devices company
      
      
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      Familiarity with quality systems, ISO 13485, MDD 93/42/ECC, MDR 2017/745, MDSAP
      
      
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      Knowledge of business management systems such as LABSQ and QUMAS
      
      
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      Knowledge of MS Office
      
      
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      Strong written/verbal communication skills
      
      
      Nice-to-haves:
      
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        Degree in Engineering, Chemistry, Biology, 5 years of experience in quality for a medical equivalent, or MBA
        
        
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        Exceptional organizational skills and ability to plan and implement resolutions to problems
        
        
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        Strong project management experience
        
        
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        Experience in analyzing test results, test method validation and release approval
        
        
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        Proven experience in leading teams and developing personnel
        
        
        Frequently Asked Questions?
        Job Location US-WA-Seattle
        Posted Date 5 months ago (12/19/2022 11:03 AM)
        ID 2022-1802
        Department Quality
        Type Regular Full-Time

Keywords: Ivoclar Vivadent, Seattle , Quality Assurance & Regulatory Affairs Manager, Executive , Seattle, Washington