Quality Engineer

Praxis Technology•Queensbury, NY

11d•Onsite

About The Position

Reporting to Quality Assurance Manager, the Quality Engineer is responsible for projects and support of production. The Quality Engineer leads and supports improvements to ensure the consistent quality of product. The Quality Engineer maintains, analyzes and improves Praxis Technology’s Quality Management System to meet customer’s expectations, company objectives and applicable regulations and standards. The ideal candidate must be able to work independently and as a team, have a strong work ethic, a positive & supportive attitude, with a strong commitment to quality.

Requirements

Bachelor’s Degree in engineering or other applicable area
5+ years of experience in a quality role in support of the medical device or aerospace related industry
Excellent interpersonal skills, with ability to collaborate with and support all levels of associates
Demonstrated ability to assess priority, complete tasks, work independently and proactively
Proven attention to detail and focus in an active environment - required
Demonstrated verbal and written communication skills, organized and effective technical writing
Proven success working in a team environment
Working knowledge of statistical techniques, and data analysis
Experience in application of risk evaluation, root cause analysis, and CAPA tools for improvement and corrective analysis
Demonstrated experience with measurement devices such as calipers, micrometers, optical measuring system
Experience in writing production, quality and safety procedures and/or qualification protocols and documents
Experience in supplier control, including supplier selection, evaluation, qualification, and auditing.
Proven history working with Quality System Regulation, Good Manufacturing Practices and ISO 13485

Nice To Haves

Working knowledge of ISO 9001 and/or AS9100 - desired
Demonstrated experience applying improvement methods, such as lean manufacturing principles and/or Six Sigma training
Experience leading Internal and/or external audits
Working knowledge of MasterControl or an electronic QMS
ASQ certification

Responsibilities

Lead and participate in the development and implementation of quality systems and procedures to ensure compliance with applicable regulatory requirements, standards, and company policies.
In house knowledge expert of Praxis parts and processes. Train, audit, and support others in production tasks and methods.
Determine and complete qualification activities for new products and processes and perform tests according to protocols and procedures.
Lead the equipment maintenance and calibration programs.
Lead non-conforming material investigations, corrective and preventive actions, internal audits and training programs by analyzing data, creating tools, determining risks and gaps, managing data and reporting.
Lead and participate in supplier selection, evaluation, and qualification processes to ensure that suppliers meet quality standards and regulatory requirements.
Develop and maintain supplier quality agreements, and lead and participate in supplier audits to ensure that suppliers are meeting quality requirements.
Conduct quality reviews of the Device History Record. Ensure production documents (record sheets, material labels, shipping paperwork) are complete and accurate.
Evaluate incoming materials, and supplier processed materials into production. Examine documents and material for differences, report findings internally and to suppliers, and complete material disposition.
Review certification documents for final release to shipping.
Investigate and resolve discrepancies. Document resolution, findings and actions via memos, reports.
Identify, champion and support improvement projects (LEAN and Six Sigma) in quality, productivity, and/or safety.
Define and draft new procedures, engineering specifications, reports and record sheets. Review and support the release of new documents. Review and revise documents for change control.
Create spreadsheets, internal standards and methods to improve output and consistency. Create and implement quality controls, process sampling, and inspection procedures.
Maintain compliance with Praxis’ Quality Management System.
Ensure compliance with OSHA guidelines and apply best practices for on-the-job safety in a production environment.
Adhere to quality assurance procedures and processes while maintaining an orderly production facility.
Continually mentor and develop the quality engineering and quality control team while fostering working relationship with and between team members.
Serve as a subject matter expert in quality assurance and participate in cross-functional teams to support product development, improvement, and release.