Quality Assurance Manager Job
Northwest Manufacturing company has 2 current openings. They are as follows
Quality Manager
Description Summary:
The Quality Manager will manage the development, modification and maintenance of all elements of our Quality Management System in compliance with policies, laws, and regulations.
Primary Responsibilities:
• Develops and maintains specifications for sterile packaging.
• Investigates and documents product quality reports, non-conforming material reports, and maintains improvement action (corrective and preventive action) system.
• Manages a staff of Quality Assurance inspection personnel.
• Manages the auditing process of quality systems.
• Identifies opportunities for product and process quality improvements and ensures that improvement action plans (including corrective and preventive action) are initiated, executed, and documented in a timely manner.
• Acts as Management Representative for Management Reviews, etc.
• Regulatory and oversight of the following:
o FDA/QSR (21 CRF 820)
o FDA 510K’s
o ISO 9001:2008
o ISO 13485
o ISO 11607,
Requirements
Qualifications required:
• Absolute requirement: Experience in sterile packaging design, application and/or manufacturing
• Absolute requirement: Experience with sterilization methods, process validation, including sterile packaging validations and sterilization validations, and sterility assurance.
• Thorough working experience with requirements of ISO standards (ISO 9001:2008, ISO 13485, ISO 11607), and GMPs.
• Familiarity with the practices of Lean Manufacturing and Continuous Improvement.
• Familiarity with the PPAP processes.
• Demonstrated practical experience and efficiency in statistical methodologies, including six sigma, statistical process control, and design of experiments.
• Technical and verbal ability to represent company during customer and regulatory audits and inspections.
• Demonstrated ability to write product and material specifications, policies, procedures, and work instructions.