Technology Research Manager jobs in Idaho Falls, ID

Job Summary

Managing Quality Assurance focusing on auditing functions of the quality unit and microbiological, controlled environment, ISO, cGMP, FDA compliance, and other certifications.

Essential Duties And Responsibilities

• Review and revision of various GMP and ISO documents
• Oversee the Quality Assurance team.
• Maintain Quality Manual and SOP's.
• Perform APR's (Annual Product Reviews) for OTC and medical devices.
• Support Environmental testing and monitoring program of the facilities and controlled environment.
• Oversee and support Customer Complaints, CAPA, Root Cause Analysis, and Change Control activities.
• Support activities within the organization to improving quality.
• Support engineering and validation activities. Responsible for process validation protocol writing and final report generation.
• Prepare and review reports related to environmental monitoring, engineering and validation activities.
• Host and support Customer and Regulatory audits.
• Perform qualification activities as needed and review of environmental controls (controlled environment, hoods, temperature and humidity).
• GMP annual training and orientation training.

Ideal Candidate Qualifications:

• Knowledge of GMP requirements pertaining to the personal care, OTC, and/or Medical Device industry.
• High attention to detail
• Must be able to communicate effectively in writing and verbally in the English language.
• Good communication skills are required. Must be able to effectively and professionally communicate deviations and other information with peers necessary for compliance.
• Must be able to perform mathematical calculations and verify the accuracy of calculations by others.
• Knowledge of lean manufacturing principles and other continuous improvement tools.
• Must be able to perform basic research functions and manipulate information effectively.
• Must have knowledge of how to operate and use a computer.
• ERP
• Microsoft Excel
• Microsoft Word
• Internet applications

Education/Experience

• BS Degree or related field.
• Experience in quality in manufacturing environment/ in Medical Device Industry.

Work Environment

• Office setting
• Noise level is usually moderate
• Fast paced
• Production and warehouse environment
• Physical testing and microbiological laboratory

Job Type: Full-time

Pay: $75,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

People with a criminal record are encouraged to apply

Application Question(s):

• Do you have Quality Assurance experience in Medical Device Industry ?

Ability to Commute:

• Idaho Falls, ID 83401 (Required)

Work Location: In person