Quality Assurance Engineer, MDR

Job Order #: 16928084

Chelmsford, MA 01824

Full Time

40 hours per week

POSTED 6/2/2022

EXPIRES 8/31/2022

Job Description

Position Summary

This position provides 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
-    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.

Education / Experience Requirements
-    Bachelor degree in Engineering is required.
-    1-2 years of Quality Assurance and/or Quality Systems work experience required.
-    Experience in a manufacturing environment, with preference in 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.

How To Apply

Please email your resume to thavrith.thao@masshirelowellcc.com for consideration


16 Elizabeth DRIVE
Chelmsford, MA 01824

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Thavrith Thao


Business Services Representative






107 Merrimack Street
Lowell, MA 01852