Job details
Salary $45 - $55 an hour job type full-time contract number of hires for this role 1
Qualifications
Bachelor`s (required)
Full job description
The quality engineer will play a key role in supporting risk management and post market surveillance activities for life science (lsg) and clinical diagnostics (cdg) productsActivities will include: updating legacy files on older products as part of remediation project
Leads and/or facilitates risk management and post market surveillance activities including updating and maintaining risk management files.
Compiling and analyzing information to identify unacceptable trends and benefit-risk conclusions with the goal of driving suitable corrective actions needed to maintain safe and effective products.
Assess and update, as required, product risk management files related to the change control, manufacturing process control, design control, complaint and capa programs.
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Qualifications:
Bachelor’s degree or equivalent in a related technical discipline
2+ years’ experience or equivalent combination of education and experience
Advanced understanding of gmp/iso regulations and validation regulations (iso 14971, iso 13485, mdsap and fda cfr part 820), and fda cfr part 210/211 preferred.
Skilled in statistical methods, statistical process control, design control and change management within a regulated environment
Basic understanding of risk management regulations, principles and application.
Quality engineering, six sigma green or black belt certification desirable
Excellent critical thinking, problem solving, coordination, team work, communication, technical and computer skills.
Sap experience a plus.
Equal opportunity employer/veterans/disabled
To read our candidate privacy information statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The company will consider qualified applicants with arrest and conviction
Job types: full-time, contract
Pay: $45.00 - $55.00 per hour
Benefits:
401(k)
Dental insurance
Health insurance
Life insurance
Referral program
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to friday
Education:
Bachelor`s (required)
Experience:
Quality engineer: 2 years (required)
Medical device: 2 years (required)
Capa: 2 years (required)
Remediation : 1 year (required)
Work location: remote
