Quality Assurance Engineer
Company: Sunstar Inc
Location: Schaumburg
Posted on: June 15, 2022
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.Job
Functions:
- 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 ManagementEducation:
- Technical 4-year degree, preferably Bachelor of Science in
EngineeringExperience:
- 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
standardSkills/Abilities:
- 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
- Excellent computer skills.
- Excellent communication skills: Written and Oral.
- Ability to organize and manage multiple priorities.
- Ability to communicate , interact and work effectively with
people from all levels of the organization.Benefits:
- 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 programsEmployee
Perks:
- On-site caf-- 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 -#CBEqual
Opportunity Employer/Protected Veterans/Individuals with
DisabilitiesThe 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)
Keywords: Sunstar Inc, Schaumburg , Quality Assurance Engineer, Engineering , Schaumburg, Illinois
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