Quality Assurance Engineer

Sunstar Inc

Job Description

Sunstar Americas, Inc. is a global leader in the oral care industry and the manufacturer and distributor of GUM oral care products and solutions.  We serve dental professionals and consumers in 80 countries worldwide and are driven by a mission: to enhance the health and well-being of people everywhere through high-quality, innovative oral care products and solutions.

The Quality Assurance Engineer will provide leadership to the quality technical team taking responsibility for new product testing, test method development, process and design validations, data analysis, competitive testing, and quality improvement projects.

In this position you will use your experience to:

  • Participate in the product development process as required to ensure that customer requirements are met
  • Perform product validation testing, develop test methods, protocols, and issue reports as needed
  • Support the process and product FMEA, and Risk Management activities
  • Monitor and analyze effectiveness of process controls in support of validation maintenance
  • Lead and facilitate CAPA project teams as required to ensure continuous quality improvement
  • Assume the facility customer complaint responsibilities regarding failure analysis, root-cause investigation, and corrective action as required per corporate policy
  • Participate in the development, execution, analysis and reporting of first-article qualification and process validations at both SAI and suppliers facilities as required
  • Perform and document equipment and process Capability Studies
  • Conduct analytical testing and root cause analysis for process nonconformance
  • Develop and prepare facility quality performance reports, charts, and graphs as needed for management decision making.  
  • Conduct comparative tests on competitive products, issue evaluation reports
  • Lead six sigma projects as assigned by SAI Management
  • Provide technical leadership for the quality team 
  • Support the internal auditing program
  • Other duties as assigned by the Quality Management

The ideal candidate will possess:

  • Technical 4-year degree, preferably Bachelor of Science in Engineering
  • Minimum 3 years Quality Control experience in a medical device manufacturing facility
  • Familiarity with quality engineering methods
  • Excellent computer skills. Experience with MS Office applications
  • Knowledge of FDA regulations and ISO 13485 standard
  • Must possess excellent written and verbal communication skills, team facilitation skills, advanced problem-solving skills, and the ability to communicate effectively with all levels within the organization


  • Comprehensive insurance coverage that includes Medical, Vision, Life and disability insurance plans along with enhanced Dental benefits
  • Wellness program including an onsite fitness center
  • 401K retirement plan with 5% employer match (Pretax and Roth options)
  • 401k profit sharing contribution based on company performance 
  • Paid holidays and generous paid time off
  • Competitive annual bonus and sales incentive programs

Employee Perks:

  • On-site café featuring daily specials with dinner-to-go options
  • Miles of beautifully maintained walking trails
  • Numerous employee appreciation events throughout the year
  • Professional development and training classes 
  • Flexible schedule including work from home options


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job Requirements