Quality Assurance Engineer

New Today

50% Onsite, 50% Remote
Education: •Bachelor's in Engineering • ASQ or related quality certification is preferred.
Requirements: • 3+ years relevant work experience • Prior experience within a manufacturing environment and data analytics • Demonstrated ability to analyze, evaluate, and control risk following lifecycle risk management standards (e.g. ISO 14971) • Experience with manufacturing / quality methodologies such as QFD, six-sigma, lean, etc. • Understanding of statistical analysis techniques and tools. • Experience with formal quality systems such as ISO 13485 or ISO 9001. • Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc. • Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems. • Able to be flexible and adaptable when needs and priorities change Physical demands and work environment
Top Skills: • Ability to work unsupervised, strong work ethic, self-starter • Experience working with data, comfortable with data analysis • Comfortable reading and understanding blueprints and other technical data • Strong interpersonal skills and attention to detail • Organized and able to multitask.
Nice to Have Skills: • Project management experience • Experience working with FDA regulations or other regulated fields • Supplier quality experience
Job Duties: • Quality Assurance Engineer will be working closely with the supplier quality team to address gaps within supplier quality and distribution systems. • They will be expected to pull and review data and work with internal and external groups to implement solutions. • The Quality Assurance Engineer provides technical support for various quality system processes to help ensure excellent product quality throughout product lifecycles. • Drive continuous improvement actions focused on product quality. • Works with Engineering and Manufacturing to develop acceptance criteria for production processes. • Works with Service and the Complaint Handling Unit to investigate product problems, perform root cause analysis and identify possible corrective actions. • Analyzes production quality data to identify trends or issues which require action or CAPA activity. • Assists in creating and implementing procedures in the quality management system. • Assists in the review and disposition of nonconforming materials. • Assists in the creation and validation of manufacturing processes. • Conducts internal audits of production processes and report results. • Reviews manufacturing process and part deviations. • Creates quality alerts when acceptance activities need to be adjusted. • Supports external regulator or customer audits • Provides response to inquiries related to quality assurance arising from tenders or other sales efforts.
**Only those lawfully authorized to work in the designated country associated with the position will be considered.**
**Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
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Location:
Skaneateles Falls

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