Quality Engineer

This role will support the development and manufacture of medical devices, maintaining safety, effectiveness, and compliance. Working closely with contract manufacturers and suppliers of sourced finished goods, this role owns assigned quality-system processes, provides quality oversight throughout the product lifecycle, and helps resolve product, process, and quality issues.

We're a growing team, and quality is central to how we build. If you're an engineer who wants to move beyond checklists and actually influence product and supplier decisions, we'd like to hear from you.

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 good Design History File.
• 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 per approved protocols or test plans.
• Perform first article inspections for newly sourced finished goods and their components.
• Generate technical reports to summarize 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 to determine root cause and develop any necessary corrective and/or preventive actions.
• Assist in the development of product/process risk management documentation.
• Assist with the resolution of CAPAs and NCRs.
• Support post-market quality monitoring and feed relevant findings into CAPA, risk management, and change control.
• Support in customer complaint investigations and SCARs, as necessary.
• Review engineering drawings for components and finished products.
• Utilize statistical analysis tools to analyze and summarize product and process data.
• Promote an environment of compliance with internal policies and procedures.
• Other duties, as assigned.

Qualities

• Strong critical thinking and problem-solving abilities.
• Basic understanding of facilities and process utility systems.
• Basic understanding of the use 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.
• Proficient in MS Office suite of products and Statistical Analysis software (e.g., Minitab)
• Strong attention to detail and ability to prioritize tasks
• Able to read and write technical specifications and reports
• Able to work in teams and interact positively with staff
• Excellent verbal and written communication skills (including analysis, interpretation, and reasoning)

Qualifications

• 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