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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. The ideal candidate will work independently and as part of a team, possess a strong work ethic, a positive attitude, and a commitment to quality.

Responsibilities

Lead and participate in the development and implementation of quality systems and procedures.
Serve as an in-house expert on Praxis parts and processes, training, auditing, and supporting others.
Determine and complete qualification activities for new products and processes, and perform tests.
Lead 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 findings and actions.
Identify, champion, and support improvement projects (LEAN and Six Sigma).
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

Bachelor’s Degree in engineering or other applicable area.
5+ years of experience in a quality role supporting the medical device or aerospace 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.
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.
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.
Ability to lift up to 50 lbs.
Ability to stand or sit for a prolonged period of time.
Visual functions include acceptable or corrected near vision, depth perception, and ability to adjust focus.
Talking and hearing occur continuously.
Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard or operate equipment.
Moderate exposure to physical risk.

Skills

Working knowledge of statistical techniques and data analysis.
Working knowledge of ISO 9001 and/or AS9100.
Working knowledge of MasterControl or an electronic QMS.
ASQ certification.

Location

Production environment

Work Type

Full-time

Experience Level

5+ years of experience

Education Level

Bachelor’s Degree

Benefits

Employee and/or Employee + Child(ren) medical insurance for $1/month
Comprehensive Dental + Vision
401k Retirement Plan with up to 3% match
Basic Life AD&D Insurance
Employee Assistance Program
18 days Paid time off (pro-rated)
9 Paid holidays
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.