Quality Engineering Technician

Praxis Technology; Town of Queensbury (NY); Vor Ort; USD 60.000 - 85.000; Vollzeit

Benefits dieser Stelle

Health insurance $1/month

401k with company match

Life AD&D Insurance

Employee Assistance Program

Paid time off - 18 days

Paid holidays - 9 days

Annual performance bonus potential

Profit sharing

Tuition assistance

Shift differential: 2nd +1/hr, 3rd +3/

Zusammenfassung

Praxis Technology is seeking a Quality Engineering Technician to help ensure the production of high-quality medical device products. You will uphold our QMS, perform root cause analysis, and drive CAPA activities to prevent recurrence while collaborating with cross-functional teams.

The role emphasizes auditing, inspections, and continuous improvement initiatives, with a strong emphasis on ISO 13485 and regulatory compliance.

Qualifikationen

• Strong analytical and problem-solving abilities required.
• Familiarity with quality management systems and tools.
• Detail-oriented with a focus on root cause analysis.
• Excellent interpersonal and collaboration skills across levels.
• Demonstrated verbal and written communication and technical writing.
• Working knowledge of ISO 13485.

Aufgaben

• Perform root cause investigations of non-conformities and implement corrective actions.
• Support CAPA to improve the quality management system.
• Maintain computerized maintenance management system; enter equipment changes.
• Support calibration program; ensure timely calibrations.
• Create and implement quality controls with monitoring, sampling, and inspection methods.
• Develop and implement quality systems, records, and procedures for regulatory compliance.
• Assist internal audits to assess QMS effectiveness.
• Conduct regular inspections and audits to identify defects or non-compliance.
• Provide training to employees on quality standards.
• Support external audits by regulators and customers.
• Lead continuous improvement projects in quality, productivity, and safety.
• Monitor quality metrics and trend analysis.
• Review lot history records and issue certificates of conformance.

Kenntnisse

Strong analytical and problem-solving

Quality management systems

Root cause analysis

Interpersonal skills

Verbal and written communication

Technical writing

ISO 13485 knowledge

Tools

Quality management tools

Jobbeschreibung

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.

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!
• 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 to work independently and as a team, have a strong work ethic, a positive attitude, and strong commitment to quality.

This position requires access to information or technology that is subject to the International Traffic in Arms Regulations (ITAR). Holders of temporary visas such as H-1B, L-1, F-1, J-1, TN, or standard temporary EAD work permits do not meet the 'U.S. Person' definition and cannot be considered for this role. For consideration, you must be a U.S. citizen, a lawful permanent resident (Green Card holder), or an individual granted refugee or asylum status in the U.S.

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