Quality Engineer 1, Product Quality Assurance

Teleflex•Chelmsford, MA

2d•$72,200 - $108,300•Onsite

About The Position

Supports the Product Quality Assurance team by analyzing post-market data and potential product quality issues for commercialized devices. Accountable for a broad range of technical assignments in the Quality Assurance area under general supervision and working with cross-functional investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ISO 13485, and 14971.

Requirements

BS Degree in Engineering (or a related technical field)
0-2 years of related (medical device preferred) experience
Computer literate (i.e., statistical software and analysis, Excel, word processing for report generation, PowerPoint presentations, etc.).
Positive attitude and ability to operate and communicate effectively with multiple teams & leadership.
Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems/conflicts, and proactively effect change.
Positive attitude and ability to operate and communicate effectively with multiple teams & leadership.
Ability to reason, support, and prioritize projects, adapt to shifting priorities, effectively solve problems/conflicts, and proactively effect change.

Responsibilities

Create, investigate, and/or manage nonconformances, as well as associated ship holds and product disposition.
Investigate, compile, and report on information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products are warranted.
Work closely with Manufacturing sites, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory to investigate and document quality issues.
Assist with compilation and analysis of product quality metrics for presentation to Global and business unit leadership.
Utilize basic statistical techniques to identify rates, changes in trends, or estimated occurrences based on bench and field data.
Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to respond to Product Quality issues.
Assist during regulatory inspections and/or audits as required.
Utilize SAP, Agile, and other systems as warranted for data input and quality record maintenance.
Communicate and escalate Quality issues appropriately to the QA Manager and address other items as assigned by the Manager.