Quality Engineer

Praxis Powder Technology, Inc.; Town of Queensbury (NY); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision

401k with match

Life AD&D Insurance

Employee Assistance Program

Paid time off

Paid holidays

Bonus potential

Profit sharing

Tuition assistance

Job summary

Praxis Technology is seeking a Quality Engineer to lead quality systems, supplier qualification, and continuous improvement within a production environment. The role requires hands-on quality assurance, data-driven problem solving, and strong teamwork to ensure device and process quality.

The ideal candidate has 5+ years in medical device or aerospace quality roles, familiarity with ISO 13485 and GMP, and proven experience with CAPA, audits, and document control.

Qualifications

• Bachelor’s degree in engineering or related field is required.
• 5+ years in quality roles in medical device/aerospace is required.
• Strong knowledge of quality systems and regulations (ISO 13485, GMP).
• Experience with LEAN and Six Sigma methodologies.

Responsibilities

• Lead development and implementation of quality systems and procedures to ensure regulatory and company standards compliance.
• Audit, train, and support production tasks and methods; act as in-house expert on Praxis parts and processes.
• Manage supplier quality, supplier audits, and CAPA investigations to improve quality and reduce risk.
• Oversee device history records review and documentation accuracy for release to shipping.
• Mentor quality engineering and quality control teams and collaborate cross-functionally on product development and release.

Skills

Quality management

LEAN Six Sigma

Statistical analysis

CAPA

Internal audits

Cross-functional collaboration

Documentation

Education

Bachelor’s Degree in engineering

Tools

MasterControl

QMS software

Job description

Are you ready to work for a company that truly cares about making a meaningful difference in this world?

A little about us:

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. It's pretty cool stuff!

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

What we can offer you:

In addition to being part of a locally owned & operated business who values treating everyone with integrity & respect, we offer the following benefits to our full-time employees:

• 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 – 9days
• Annual Performance Bonus Potential & Profit Sharing Program
• Employee Profit Sharing
• Tuition Assistance
• We are currently unable to sponsor applicants for this role.

Position Summary

Reporting to Quality 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.

What You’ll Make an Impact

• 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.

What You Must Bring to This Role

• 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
• 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
  

We are currently unable to sponsor applicants for this role.

Working Conditions & Physical Efforts

• Work is performed in a Production environment
• 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

Praxis is an equal opportunity employer