Quality Engineer

HR HealthCare•Springettsbury Township, PA

24d•Onsite

About The Position

HR HealthCare is a fast-growing medical device company that develops, manufactures, and supplies healthcare products. The Quality Engineer supports medical device development and manufacture by helping maintain product safety, effectiveness, and compliance. The role serves as a technical voice for sourced finished goods and works hands-on with contract manufacturers, suppliers, and cross-functional teams to address product and process issues. The position owns assigned quality-system processes and provides quality oversight throughout the product lifecycle. It maintains quality-system documentation and risk-management records; supports design history files, product specifications, verification and validation reviews, inspections, testing, and technical reporting; and helps resolve quality issues through root-cause analysis, corrective and preventive actions, CAPAs, and nonconformance processes. The role also supports post-market quality monitoring, customer complaint investigations, supplier corrective actions, and change control.

Requirements

Bachelor’s degree program in engineering or a related field; mechanical or biomedical engineering preferred.
3–5 years of product quality, development, and/or manufacturing-related experience or equivalent, particularly in an engineering or technical role.
Strong critical-thinking and problem-solving abilities.
Basic understanding of facilities and process utility systems.
Basic understanding of statistical analysis tools.
Ability to read and interpret engineering drawings, wiring diagrams, and P&IDs.
Experience investigating quality issues and applying structured root-cause analysis methods.
Working knowledge of ISO 13485, FDA QMSR requirements, design and development controls, CAPA, nonconformance management, and document control.
Understanding of OSHA and manufacturing safety.
Proficiency with Microsoft Office and statistical analysis software such as Minitab.
Strong attention to detail and ability to prioritize tasks.
Ability to read and write technical specifications and reports.
Ability to work in teams and interact positively with staff.
Excellent verbal and written communication skills, including analysis, interpretation, and reasoning.

Nice To Haves

Mechanical or biomedical engineering education is preferred.

Responsibilities

Maintain and improve assigned quality management system procedures, records, and controls.
Coordinate maintenance of the risk management file and facilitate cross-functional reviews using the company's ISO 14971-based risk management process.
Draft, revise, and maintain sourced finished-goods Design History Files.
Review product verification and validation testing protocols and reports for acceptance criteria, data integrity, deviations, and documented conclusions.
Develop product specifications, acceptance criteria, and related sampling plans as needed.
Review testing conducted under approved protocols or test plans.
Perform first article inspections for newly sourced finished goods and their components.
Generate technical reports summarizing evaluation results.
Develop and prepare specifications, work instructions, visual aids, and other documentation for inspection and testing of sourced finished goods.
Work with contract manufacturers and suppliers to troubleshoot component and product issues, determine root causes, and develop necessary corrective and preventive actions.
Assist in developing product and process risk-management documentation.
Assist with resolution of CAPAs and NCRs.
Support post-market quality monitoring and feed relevant findings into CAPA, risk management, and change control.
Support customer complaint investigations and SCARs as necessary.
Review engineering drawings for components and finished products.
Use statistical analysis tools to analyze and summarize product and process data.
Promote compliance with internal policies and procedures.
Perform other duties as assigned.