MDR Quality Engineer

Position Summary

The MDR, Quality Assurance Engineer will provide Quality Engineering support to the Quality Management System for the Chelmsford site. 

The primary purposes and objectives include:
•    Nonconformance and Corrective & Preventive Action coordination and processing.
•    Support the Incoming & In-Process Inspectors with Nonconformance Activities.
•    Provide input and gather data for the monthly Quality System Review Board (QSRB).
•    Provide input and gather data for the quarterly Quality Management Reviews (QMR).
•    Support the Value Stream as a Quality Engineer (QE) on NC and CAPA investigations.
•    Support the Value Stream as a Quality Engineer with risk evaluation and field corrective actions (EIF) as needed.
•    Internal & external auditing responsibilities and support. 
•    Support the training department as needed.
•    Quality improvement projects; and 
•    Maintain compliance with Teleflex Global & local procedures and policies.
 

Principal Responsibilities

The key areas of responsibility are:
•    Nonconformance (NC) and CAPA processing – lead quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and drive improvement through analysis of trend data. 
•    Support Incoming & In-Process Inspection teams.
•    Prepare QSRB and QMR slides as needed.
•    Support the Value stream with investigations required for field corrective actions including risk evaluation.
•    Perform internal audits and support supplier corrective actions as needed.
•    Quality & Cost Improvement Projects – lead and participate on key short-term projects on product or process improvements.
•    Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and Process run sheets 
•    Auditing – routinely perform internal and process related audits. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits. 
•    Documentation Control – perform change controls (ADC/ECOs) as needed. 
•    Training – Perform QA training certifications on new production operators as needed.
•    Support Engineering with new product development with quality planning, risk evaluation and validation. 
•    Perform any additional QA tasks, as assigned by QA Manager or Plant Manager. 

This position requires direct contact with an implantable device.      ☐ Yes     ☒ No 
 

Education / Experience Requirements

Bachelor’s degree in engineering, chemistry, physical science, or a related field is preferred, or 3+ years of Quality Assurance experience working in a medical device manufacturing environment.
•    Experience in a manufacturing environment, with a preference for a regulated or medical devices industry. 
 

Specialized Skills / Other Requirements

•    Knowledge of QSR, CFR, cGMP, and ISO regulations (required)
•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required. 
•    Experience with Minitab and SAP, ERP is preferred. 
•    Working knowledge and/or experience with SAP and AGILE strongly preferred.
•    Statistical Techniques preferred (DOE, SPC, and Gage R&R).
•    Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc)
•    Good listening, verbal and written communication skills 
•    Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•    Ability to prioritize and adapt to shifting priorities.
•    Ability to work independently with limited supervision.

TRAVEL REQUIRED: As needed to support customers < 5%
 

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