QA Engineer II

Start Date: ASAP
End Date: 6 Months From start
Location: REMOTE Prefer candidates in Eastern Time Zone

**Other Notes: Highly prefer someone with prior Philips Medical Device experience. **

Description:
Independently produces and completes Quality Engineering Documents Responsible for performing timely quality engineering tasks like assessing quality plans assessing product designs and reviewing test and other performance data analyses market feedback lead root cause analysis and quality problem solving. May also provide other quality engineering support including assisting organizational units in leading resolution of quality engineering deficiencies Developing professional expertise applies company policies and procedures to resolve a variety of issues. Fully qualified managers who have advanced beyond entry level Has working knowledge of company products and services Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others conducting presentations of technical information concerning specific projects or schedules Works on issue of diverse scope where analysis of situation or data requires evaluation of a variety of factors including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinates to meet schedules and /or solve technical problems .Develops and administers schedules performance requirements. Probably has budget responsibilities .Reporting Line. Reports to quality Engineer products and Systems Grad 70 or Quality Manager Products and Systems Grade 80 or Head of Quality. Experience Background . Bachelors engineering degree or equivalent experience. Working knowledge of appropriate global regulations requirements and standards 3-4 years of related experience in a medical device or other regulated industry.
The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. The Quality Engineer provides independent oversight of the design input process design VV activities design transfer and product realization and performance in the field to ensure that all design requirements are effectively met. The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes
This contingent role is required in order to deploy PDLM and other PEPF processes in CDS
*21 CFR
*ISO 9001
*Medical Device documentation and QA planning 2 yrs and 4yrs
*Philips background preferred big medical device manufactures.
*Remote is acceptable but only EST time zone.
*JJ Medtronic's

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.