Quality Engineering Technician

Praxis Powder Technology, Inc.; Town of Queensbury (NY); On-site; USD 55,000 - 90,000; Full time

Benefits offered by this job

Low-cost health insurance

Dental & Vision

401k with match

Life AD&D

Employee Assistance Program

Paid time off 18 days

9 paid holidays

Bonus potential

Profit sharing

Tuition assistance

Shift differential

Job summary

Praxis Powder Technology, Inc. is seeking a Quality Engineering Technician who will ensure high-quality production and maintain our quality management systems.

You will work both independently and with a team to uphold regulatory requirements and a strong commitment to quality. The role requires hands-on experience in a manufacturing quality environment, familiarity with ISO 13485, and the ability to lead audits and continuous improvement initiatives.

Qualifications

• Minimum two (2) years experience working in a Quality Department in a manufacturing environment.
• Experience within Medical Device or other regulated industries preferred.

Responsibilities

• Perform root cause investigations of non-conformities; implement corrective and preventive actions (CAPA).
• Maintain the computerized maintenance management system by entering new equipment and changes.
• Support the calibration program by ensuring timely calibrations.
• Create and implement quality controls via monitoring, sampling and inspection methods.
• Lead and participate in development and implementation of quality systems, records, and procedures to ensure regulatory compliance.
• Support internal audits to assess effectiveness of the quality management system.
• Conduct regular inspections and audits to identify defects and non-compliance.
• Provide training and support to employees to ensure adherence to quality standards.
• Support external audits from regulatory bodies and customers.
• Identify and support continuous improvement projects in quality, productivity, and safety.
• Support quality metrics trending and analysis.
• Perform lot history review and release manufacturing lots; issue certificates of conformance.

Skills

Quality experience

Analytical skills

Problem solving

QMS familiarity

Root cause analysis

Interpersonal skills

Technical writing

ISO 13485

Tools

CAPA process

Job description

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

Culture

Join a team that makes innovations reality, owns the process and demands excellence all while supporting your work-life balance with flexible schedules, ample vacation time to rest and recharge, and a relaxed atmosphere so you can focus on what matters — doing good work that makes people’s lives better.

We value people that are highly motivated, self-starters open to learning new things every day. We’re looking for people with a good attitude and strong character who strive to be the best at what they do, take accountability for their actions and are determined and committed to get the job done.

Benefits

We’re a company that values you and your career path and recognizes the importance of work-life balance.

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

• Employee and/or Employee + Child(ren) medical insurance costs you 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
• Employee Profit Sharing
• Tuition Assistance
• Shift differential: 2nd shift – + $1/hr, 3rd shift – + $3/hr

We pride ourselves on being a community-minded company that provides lots of opportunity to learn, grow and be at your best every day.

Position Summary

Reporting to Quality Manager, the Quality Engineering Technician plays a crucial role in ensuring the production of high-quality products while maintaining and improving our quality management systems to meet regulatory requirements. The ideal candidate must be able towork independently and as a team, have a strong work ethic, a positive attitude, and strong commitment to quality.

How You’ll Make an Impact

• Perform root cause investigations of non-conformities; implementing corrective and preventative actions to prevent recurrence.
• Support Corrective and Preventive Actions (CAPA) to continuously improve the quality management system.
• Maintain the computerized maintenance management system by entering new equipment and equipment changes.
• Support the calibration program by ensuring timely completion calibrations.

• Create and implement effective quality controls by establishing monitoring, sampling, and inspection methods.

• Lead and participate in the development and implementation of quality systems, records, and procedures to ensure compliance with applicable regulatory requirements, standards, and company policies.
• Support internal audits to assess the effectiveness of the quality management systems.

• Conduct regular inspections and audits to identify defects, deviations, or non-compliance issues.
• Provide training and support to employees to ensure adherence to quality standards.

• Support external audits from regulatory bodies and customers.

• Identify, champion and support continuous improvement projects in quality, productivity, and/or safety.
• Support quality metrics trending and analysis.
• Perform lot history record review, releasing manufacturing lots and issuing certificates of conformance to customers.

• Serve as a subject matter expert in quality assurance on cross-functional teams ensuring compliance to the compliance with applicable regulatory requirements, standards, and company policies.

What You Must Bring to This Role

• Minimum two (2) years experience working in a Quality Department in a manufacturing environment.
  • Experience within Medical Device or other regulated industries preferred.
• Strong analytical and problem-solving skills
• Familiarity with quality management systems and tools
• Detail-oriented with a focus on root cause analysis
• Excellent interpersonal skills, with ability to collaborate with and support all levels of associates
• Demonstrated ability to assess priority, complete tasks, and work independently
• Demonstrated verbal and written communication skills, organized and effective technical writing
• Working knowledge of ISO 13485

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