Job description

Good Labor Jobs is seeking a Quality Engineering Manager. The position is in Fayette, AL. This individual will work closely with Quality, Manufacturing and Engineering Teams to successfully implement changes to products or processes. This is a full-time position.

Responsibilities:

• Establish and maintain processes for Design Controls, Validations, Risk Management and Change Management and ensure its compliance to applicable standards (e.g. Medical Devices).
• Coordinate Quality related activities during Design Controls or changes to products or manufacturing process.
• Responsible for Process Validation activities for the facility including Master Validation Plans, Cleaning Validations, Utilities Validation, Facilities Validation, Process IQ/OQ/PQ, Revalidation Assessments
• Responsible for Risk Management documentation including Risk Management Plans and Reports, Hazard Analysis and FMEAs.
• Establish processes to incorporate trending data and new information to maintain Risk Management Files up to date.
• Establish a holistic Change Management process to ensure projects impacting product design, intended use, manufacturing process or Quality Management Systems are timely evaluated and executed in a compliant manner.
• Supports R&D’s new product development, new designs, and design changes ensuring product quality, reliability, reduction of risk to users, and regulatory compliance.
• Provide insight on projects that could change products or production processes.

Qualifications:

• Engineering Degree and/or an equivalent combination of education and experience
• 3 years or more of experience in FDA regulated industry (Medical Devices preferred)
• Working Knowledge of ISO13485:2013 and or 21 CFR 820
• Solid knowledge of FDA requirements for Design Controls, Process Validation and Risk Management
• Experience with technical writing and formatting
• Expertise on statistical tools for data analysis, sampling plans, design of experiments and process capabilities studies.

Preferred Qualifications:

• 5 years of experience in Medical Devices industry in Quality Engineering roles
• Six sigma training
• Familiar with ISO 14971
• Experience on product lifecycle for medical devices and new products introduction

Job Type: Full-time

Pay: $120,000.93 - $130,303.84 per year

Schedule:

• 12 hour shift
• Night shift

Work Location: One location

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