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About the Role

The Quality Engineer is responsible for projects and support of production, leading and supporting improvements to ensure consistent product quality. This role maintains, analyzes, and improves the Quality Management System to meet customer expectations, company objectives, and applicable regulations and standards.

Responsibilities

• Lead and participate in the development and implementation of quality systems and procedures.
• Serve as an in-house knowledge expert of Praxis parts and processes, training, auditing, and supporting others.
• Determine and complete qualification activities for new products and processes and perform tests.
• Lead the equipment maintenance and calibration programs.
• Lead non-conforming material investigations, corrective and preventive actions, internal audits, and training programs.
• Lead and participate in supplier selection, evaluation, and qualification processes.
• Develop and maintain supplier quality agreements, and lead and participate in supplier audits.
• Conduct quality reviews of the Device History Record.
• Ensure production documents are complete and accurate.
• Evaluate incoming materials and supplier processed materials.
• Examine documents and material for differences, report findings, and complete material disposition.
• Review certification documents for final release to shipping.
• Investigate and resolve discrepancies, documenting resolution, findings, and actions.
• 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 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.
• Adhere to quality assurance procedures and processes while maintaining an orderly production facility.
• Continually mentor and develop the quality engineering and quality control team.
• Serve as a subject matter expert in quality assurance and participate in cross-functional teams.

Requirements

• Must be able to work independently and as a team.
• Must have a strong work ethic, a positive & supportive attitude, with a strong commitment to quality.
• 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.
• Demonstrated verbal and written communication skills, organized and effective technical writing.
• Proven success working in a team environment.
• 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.
• Demonstrated experience applying improvement methods, such as lean manufacturing principles and/or Six Sigma training.
• Experience leading Internal and/or external audits.
• May be required to lift up to 50 lbs.
• Ability to stand or sit for a prolonged period of time.
• Visual functions being those of acceptable or corrected near vision, depth perception, and ability to adjust focus.
• Talking and hearing occur continuously in the process of communicating with associates, leadership & suppliers.
• Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard or operate equipment.
• Moderate exposure to physical risk.

Skills

• Quality Management System
• LEAN
• Six Sigma
• OSHA guidelines
• Statistical techniques
• Data analysis
• Risk evaluation
• Root cause analysis
• CAPA tools
• Calipers
• Micrometers
• Optical measuring system
• Supplier selection
• Supplier evaluation
• Supplier qualification
• Supplier auditing
• Quality System Regulation
• Good Manufacturing Practices
• ISO 13485
• ISO 9001
• AS9100
• Lean manufacturing principles
• MasterControl
• Electronic QMS
• ASQ certification

Location

• Production environment

Work Type

• Full-time

Experience Level

• 5+ years of experience in a quality role in support of the medical device or aerospace related industry

Education Level

• Bachelor’s Degree in engineering or other applicable area

Benefits

• Employee and/or Employee + Child(ren) medical insurance for just $1/month!
• Comprehensive Dental + Vision
• 401k Retirement Plan that we match up to 3%
• Basic Life AD&D Insurance
• Employee Assistance Program
• Paid time off - 18 days first year (pro-rated)
• Paid holidays – 9 days
• Annual Performance Bonus Potential & Profit Sharing Program
• Employee Profit Sharing
• Tuition Assistance

About the Company

• Praxis Technology is a manufacturing company that designs and develops titanium parts for medical devices, aerospace and other consumer markets.
• We create sustainable flexibility that delivers maximum impact to make people’s lives better.
• We value people that are highly motivated, self-starters, open to learning new things every day.
• We look for like-minded individuals who will embrace the five core values of Praxis: Team player, Driven to improve, Genuinely care, Dependable, Own.

Equal Opportunity

• Praxis is an equal opportunity employer