Senior Quality Engineer (Wayne, NJ) Defined Term

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

The Senior Quality Engineer is responsible for effective establishment and maintenance of quality systems. Leads efforts to sustain and enhance Quality Compliance, maintenance of quality systems, preparation/revision of QMS Procedures to sustain compliance.

This position is a Defined Term position for a period of one year.

Work location is Wayne, NJ where the position is 4 days a week onsite.

 

Job Responsibilities and Essential Duties

• Review Quality Manual to identify potential gaps in documented quality processes (including outsourced processes), procedures to ensure compliance to ISO13485:2016, MDSAP, and FDA Medical Device Regulations as applicable to CAHW, CADI, and Collagen businesses.
• Organize existing QMS procedures per QMS documentation hierarchy and ISO 13485:2016 Clause classifications to identify gaps and redundancies, as appropriate.
• Understand existing Quality Management System processes and procedures, identify improvement/simplification opportunities, and revise quality process / procedures to improve QMS effectiveness and efficiency.
• Compare and assess QMS procedures for similar processes in CAHW, CADI, and Collagen businesses and identify opportunity to synergize/integrate associated QMS procedures with goal to create effective and unified Quality Management System for Cardiac Assist Business
• Collaborate with Corporate Quality Team to understand expectation and plan to align with GETQMS initiative.
• Revise (create, modify, combine, obsolete) Quality Manual, QMS procedures to create an effective, efficient, and lean set of Quality Management System procedures addressing CADI, CAHW, and Collagen businesses.
• Review Quality System documents and records storage and archival practices (adobe signed documents and localized archival practices) to identify potential compliance gaps and make necessary changes to ensure compliance with ISO 13485 Document Control and retention requirements.
• Communicate, interact and coordinate quality improvement efforts with Manufacturing, QA, R&D, and engineering management.
• Identify and lead implementation of new opportunities for improvements to work processes, and other are