Overview
On Site
Depends on Experience
Contract - W2
Contract - 18 Month(s)
Skills
Quality engineering
ISO 13485
FDA 21 CFR Part 820
IVDR 2017/746
Six Sigma
CQE
CQA
quality assurance
life science
pharmaceutical industry
medical device regulations
GxP
batch review
change control
NCRs
deviations
CAPAs
audits
product complaints
root cause investigation
scientific method
R&D support
manufacturing engineering
procurement
product/process improvement
strategic initiatives
data quality
process quality
SME
quality systems
internal audits
external audits
audit preparation
team collaboration
analytical skills
communication skills
independent decision-making.
Job Details
(No C2C/H1B)
Please note that this is a 12 to 18-month contract position.
Job Posting Qualifications
- Bachelor s or Master s Degree in biology, chemistry, biotechnology, engineering, or a related field, or equivalent experience.
- Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQE, CQA, etc., is preferred.
- 4+ years of experience in a similar position within the Life science/Pharma industry.
- Medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746 is required.
- Strong organizational and analytical skills with a focus on finding effective and efficient solutions in compliance with the regulations.
- An effective communicator at all levels, both internally and externally.
- Team player with the ability to make independent decisions within the framework and guidelines of the organization.
- Relocation assistance is available.
Job Posting Description
- Our Quality Engineer role is dedicated to ensuring the highest quality experiences for our patients and customers.
- This position provides engineering guidance, expertise, and services to ensure process, data, and product quality.
- Quality Engineers lead and drive process and product improvements and provide specialized quality-related services to R&D, Quality Assurance, Manufacturing Engineering, Production, Procurement, and Marketing.
- They develop, implement, and evaluate tools and equipment for quality assurance and product/process improvement.
Additional responsibilities will include:
- Drives quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and supports Product Complaints technical investigations for the relevant product platforms.
- Support 3rd party audit of site through audit prep and participating in the front/back room.
- Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities.
- Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments.
- Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback.
- Act as an SME in quality assurance and scientific matters as applicable.
- Develop and drive key strategic quality assurance initiatives throughout the organization.
- Contributes to the development of new projects/programs/processes.
- Lead/drive root cause investigations for multiple issues, including complaints, NCRs, Deviations, OOS, etc.
- Leads projects requiring representation of the organization to internal and/or external customers or others, providing expertise and promoting solutions.
Applicants must provide their phone number. Reference job number is A4879
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