- Maintain company compliance of FDA Quality System Regulations, ISO 13485, and other applicable standards/regulations
- Work with Manufacturing and the contract manufacturer to resolve issues that involve quality gaps and production nonconformance's
- Work with suppliers to ensure timely response and appropriate investigations for supplier product quality issues
- Conduct failure investigations, root-cause analysis, and corrective action implementation.
- Develop and document Quality processes, procedures, work instructions, and/or forms
- Develop and execute test method validations and equipment qualifications
- Develop/Modify Incoming Quality Assurance sampling plans
- Provide Quality Engineering support and expertise to Manufacturing, Engineering, Marketing and other company functions, as it relates to Supplier Quality
- Review and approve protocols/reports for validation activities
- Material qualification and material acceptance ownership
- Perform other duties as assigned
- BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience
- Experience with FDA and ISO 13485 inspections preferred
- Minimum of 1 year in a Quality Engineering function working with QSR and ISO 13485 preferred
- Effective verbal and excellent technical writing skills
- Ability to communicate and work effectively at multiple levels within the organization
- Ability to organize and judge priorities
- Excels at generating and maintaining organized and accurate records
- PC skill, word processing, spreadsheet, database
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Quality Engineer - Acton, United States - Insulet Corporation
Description
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it
Job Title: Quality Engineer I
Department: Quality
FLSA Status: Exempt
Position Overview:
This position is responsible for providing Quality Engineering support for commercially manufactured product, as well as working closely with Insulet's suppliers to ensure product quality. The role provides insight and guidance to Insulet's Quality Operation processes including non-conformances, corrective and preventive actions, Process Change Order Assessment (PCOA) and resolution of manufacturing quality related issues.
Responsibilities:
Minimum Requirements:
Additional Information:
The US base salary range for this full-time position is $65, $98, Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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