Quality Assurance Specialist

3 weeks ago

Amherst, United States Ivoclar NA Full time
Location: Amherst, NY (Hybrid)

Starting Salary: starting at $60,000 based on experience

Position Responsibilities:

To support and maintain applicable Quality Management Systems in operations throughout Ivoclar Vivadent Inc. (Amherst and Mississauga).

  • Ensure the calibration program remains updated and equipment owners are appropriately notified to keep equipment in compliance
  • Ensure the Preventive Maintenance program remains updated and equipment owners are notified to keep equipment in compliance
  • Maintain Centralized Filing (Quality) and lead the archiving process
  • Lead complaint handling for Sagemax Customer Complaints
  • Responsible for the creation of Quality Certificates
  • Act as NC Coordinator for processing nonconformities
  • Responsible for local Product Elimination process
  • Responsible for Specification Development and Maintenance
  • Quality contact for temperature and humidy monitoring in the warehouse and production areas
  • Serve as Administrator and DCC for Quality System Documentation software controls (MyQUMAS). Execute all roles and responsibilities associated with the QMS documentation for Ivoclar Vivadent, Inc. Amherst and Mississauga, in conjunction with process owners, as necessary
  • Serve as Auditor on the Internal Audit Team. Perform audits, utilize Audit Management Process Compliance Tool to aid in the creation of audit reports and audit findings. Effectively communicate with Auditees and Action Owners
  • Provide support before, during and after external audits and inspections as required.

Additional Responsibilities:

  • Assist as needed with the following processes and activities:
    • Change Management
    • CAPA
    • Environmental and Safety
    • Device History Record scanning
    • Regulatory activities, including but not limited to adverse event, product recall, product withdrawal, and advisory notices
    • Quarterly Trend Reporting (GQTR)
  • Serve as deputy for the following processes:
    • Device Master Record creation and maintenance
    • Incoming inspections & Outgoing release
    • Inspection- Alloy & Valiant
    • Testing (Powders)
    • SDS’s Management
    • Supplier Qualification

Your Qualifications:

  • Bachelor's Degree or equivalent experience
  • 2+ years of quality relevant experience in a regulated industry
  • Knowledge of MS Word, Excel and Outlook
  • Strong project management experience
  • Strong analytical abilities necessary
  • Ability to multi-task and prioritize in a dynamic work environment
  • Strong organizational, written/verbal and presentation skills mandatory
  • Ability to maintain confidentiality of all information and high degree of professionalism

Physical Demands:

  • Position could involve sitting, standing and walking for long periods throughout the day. Ability to use a computer monitor and move about effectively to fulfill the essential functions of the job

Benefits Offered

  • Medical plan
  • Prescription drug coverage
  • Dental plan
  • Retirement savings plan
  • Disability benefits
  • Flexible spending account
  • Voluntary benefits
  • Time off program
  • Wellness program

Let's achieve our goal together.

If you are looking for a job where you can contribute actively, develop personally and professionally and make a lasting difference then this is the right place for you. As an international family business with a long-term perspective, we know that it is our around 3600 employees that are the key to our success. Let's achieve our goal together: Making people smile.

Ivoclar is committed to Equal Employment Opportunity and Affirmative Action and, as such, affirms in policy and practice to recruit, hire, train, and promote, in all job classifications, without regard to race, religion, color, national origin, citizenship, sex, age, veteran status, disability, genetic information, sexual orientation, gender identity or any other protected characteristic. Ivoclar will not discriminate against persons because of their disability and will make reasonable accommodations for known physical or mental limitations of qualified employees and applicants with disabilities. We will also make reasonable accommodations during the interview and selection process.

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