A company that manufactures innovative and life saving equipment is seeking a Quality Systems Specialist in Norfolk, Virginia. The ideal candidate will thrive in an autonomous work environment that is self motivating.

Responsibilities:

• Ensures conformance of Quality Systems to regulations and quality policies
• Maintains programs and processes to ensure the highest quality products and compliance to current Good Manufacturing (cGMP)
• Ensures production documents are reviewed for accuracy and compliance to quality policies
• Updates, maintains and improves quality management systems process documents and documentation
• Identifies quality risks in activities and processes according to regulatory agency guidelines and quality policies and reports deviations from approved processes and procedures
• Supports during regulatory inspections, audits and Management Reviews
• Assists in coordinating corrective/preventive actions, continual improvement, customer complaints and non-conformances and investigating root cause and effectiveness of actions taken
• Tracks, reviews and assists in organizing reporting metrics and data for use in continuous improvement and Quality Management System reviews.
• Drives continuous improvement of core processes to ensure the highest manufacturing standards and quality

Support product development by:

• Ensures conformance of Quality Systems to regulations and quality policies
• Maintains programs and processes to ensure the highest quality products and compliance to current Good Manufacturing (cGMP)
• Ensures production documents are reviewed for accuracy and compliance to company quality policies
• Updates, maintains and improves quality management systems process documents and documentation
• Identifies quality risks in activities and processes according to regulatory agency guidelines and quality policies and reports deviations from approved processes and procedures
• Supports during regulatory inspections, audits and Management Reviews
• Assists in coordinating corrective/preventive actions, continual improvement, customer complaints and non-conformances and investigating root cause and effectiveness of actions taken
• Tracks, reviews and assists in organizing reporting metrics and data for use in continuous improvement and Quality Management System reviews.
• Drives continuous improvement of core processes to ensure the highest manufacturing standards and quality

Competitive salary, full benefits package, professional growth opportunities

Job Type: Full-time

Pay: $55,267.66 - $63,868.42 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Office

Application Question(s):

• Please list which industries you worked in where you were responsible for managing and writing quality systems and SOPs.

Experience:

• Manufacturing (Required)
• Quality systems (Required)

Work Location: In person

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