Quality Manager

Position Summary

The Quality Manager will be responsible for all activities involving quality assurance and compliance with applicable standards. Responsible for the design and implementation of policies and procedures to ensure that quality standards are met. Will give support to all other departments as required. Performs a variety of tasks and leads and directs the work of others.

Duties and Responsibilities

• Collaborates with operations managers to implement and leverage Quality Management Systems (QMS) and Quality Assurance (QA) practices to enhance performance and efficiency in achieving quality outcomes.
• Performs internal audits. Addresses non-conformities from previous internal and external audits.
• Assists the management and manufacturing team in daily production meetings and reports.
• Works with the Director of Quality to maintain and continuously improve all related QMS.
• Responsible for maintenance of inspection reports and QMS records.
• Responsible for Calibration of Equipment and records.
• Works on Instruction Development (Quality plans, rework, etc.)
• Material Review Board (MRB) Dispositions
• COPQ Metrics
• Supervision of quality staff.
• Schedules the Quality Departments daily activities with guidance from the Director of Quality, assign priorities, and monitor the assignments until completion.
• Maintains a proactive approach to quality improvement.
• Other duties as assigned.

Position Qualifications

• Bachelors in Engineering or equivalent work experience in related industry required.
• 5 to 10 years’ experience in ISO 9001 required. Experience with ISO 13485:2016 preferred.
• A minimum of 5 years in a leadership role with achieved KPI’s.
• Efficient in CMM Programming (PC-DIMIS)
• Minimum of 5 years’ experience as the primary customer interface in a Quality role.

Knowledge, Skills, and Abilities

• Ability to read and interpret documents such as Quality Management Systems Standards, safety requirements, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the company.
• College level mathematics. Ability to perform statistical process control calculations to assess process capability.
• Familiarity with ITAR requirements
• Problem solving and time management.