Quality Specialist

Praxis Technology•Queensbury, NY

11d•Hybrid

About The Position

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 it. Reporting to the Quality Manager, the Quality Specialist serves as a technical quality resource supporting product quality, process quality, compliance, and continuous improvement initiatives. This position may lead and support investigations, CAPA activities, validations, internal audits, quality metrics, and risk-based problem solving while ensuring compliance with Praxis Quality Management System requirements, customer specifications, and applicable regulatory standards. The Quality Specialist partners closely with Manufacturing, Engineering, and Operations teams to drive quality performance, reduce defects, improve processes, and support customer satisfaction.

Requirements

Associate's or Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related field, or equivalent combination of education and experience.
3+ years of experience in a quality role within manufacturing, medical device, aerospace, or regulated industries.
Experience within ISO 13485 and/or AS9100 environments.
Experience with validation protocols and statistical analysis.
Experience with nonconformance management, investigations, and corrective action processes.
Strong analytical and problem-solving skills.
Ability to interpret engineering drawings, specifications, and customer requirements.
Proficiency with Microsoft Office including Excel.
Strong technical writing and documentation skills.
Excellent communication and collaboration skills.
Working knowledge of risk management methodologies.

Nice To Haves

Experience with electronic Quality Management Systems (eQMS).
Lean Manufacturing, Six Sigma, or continuous improvement experience.
ASQ Certified Quality Technician (CQT), Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE).
Experience supporting customer audits and regulatory inspections.

Responsibilities

Support and maintain compliance with the Praxis Quality Management System (QMS).
Lead or participate in root cause investigations, corrective actions, and preventive actions (CAPA).
Support nonconformance reporting, containment activities, investigation documentation, and disposition processes.
Analyze quality data, trends, scrap, rework, customer feedback, and process performance metrics.
Support validation activities, including IQ/OQ/PQ protocols and report execution.
Assist with First Article Inspection Reports, process qualifications, and production approvals.
Participate in internal audits, supplier audits, and external customer or regulatory audits.
Support risk management and quality planning activities.
Collaborate with Engineering and Manufacturing teams to improve process capability and product quality.
Review and approve quality records, Device History Records, inspection data, and supporting documentation.
Support training efforts related to quality procedures, good documentation practices, and compliance requirements.
Assist with calibration, metrology, and measurement system analysis activities, including Gage R&R studies.
Develop and maintain quality metrics, dashboards, and reporting tools.
Champion continuous improvement initiatives using Lean Manufacturing and problem-solving methodologies.
Promote a culture of quality, accountability, safety, and continuous improvement consistent with Praxis Core Values.