Quality Engineer I, Medical Device QA – Impact & Metrics

Teleflex; Chelmsford (MA); On-site; USD 72,000 - 108,000; Full time

Job summary

Teleflex is seeking a Quality Engineer 1 for Product Quality Assurance to support the QA team, analyzing post-market data and potential quality issues for commercialized devices.

You will work with cross-functional teams and understand root-cause investigations, risk management, and QMS per 21 CFR 820, ISO 13485, and 14971. This role includes nonconformances, data analysis, and collaboration with multiple departments.

Qualifications

• BS Degree in Engineering (or related technical field).
• 0-2 years of related (medical device preferred) experience.
• Computer literate (statistical software, Excel, Word processing, PowerPoint).
• Positive attitude and ability to operate and communicate with multiple teams/leadership.
• Ability to reason, support and prioritize projects, adapt to shifting priorities, solve problems/conflicts, and drive change.

Responsibilities

• Create, investigate, and/or manage nonconformances, and associated ship holds and product disposition.
• Investigate, compile, and report information for executive assessment of field actions/removals.
• Work with Manufacturing sites, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory to investigate quality issues.
• Assist with compilation and analysis of product quality metrics for leadership.
• Utilize basic statistical techniques to identify rates, trends, or occurrences from data.
• Provide clear written internal reports and support external communications for quality issues.
• Assist during regulatory inspections/audits as required.
• Utilize SAP, Agile, and other systems for data input and quality record maintenance.
• Communicate quality issues to QA Manager and other assigned items.

Skills

Statistical software

Excel

PowerPoint

Word processing

Team communication

Education

BS Degree in Engineering

Tools

SAP

Agile

Job description

Teleflex is seeking a Quality Engineer 1 for Product Quality Assurance to support the QA team, analyzing post-market data and potential quality issues for commercialized devices.

You will work with cross-functional teams and understand root-cause investigations, risk management, and QMS per 21 CFR 820, ISO 13485, and 14971. This role includes nonconformances, data analysis, and collaboration with multiple departments.