Quality Supervisor

This position supports federal contracts and requires adhering to government data protection standards.

Objectives

• Assess staffing requirements and make necessary adjustments to ensure adequate QA coverage

• Ensure QA employees are aware of work instructions, quality standards and regulatory requirements and document their training.

• Oversee in-process inspections, quality monitoring, test results and batch documentation for accuracy and completeness to approve product quality prior to release for sale.

• Monitor calibration programs to ensure testing equipment remains complaint and operational.

• Assist with creating, revising and implementing work instructions and other quality documentation.

• Ensure all functions and related documentation are completed accurately to meet regulatory requirements and business objectives.

• Work closely with cross-functional Departments to improve quality and operational efficiencies.

• Lead investigations with team related to deviations, non-conformances, complaints, and quality incidents

• Support audits, inspections, validation activities, and regulatory readiness.

• Other tasks as assigned by department management.

Tasks

• Conduct detailed analysis and evaluation of existing manufacturing processes, identifying areas for improvement and recommending appropriate solutions.

• Design and implement process optimization strategies to enhance efficiency, reduce cycle time and improve product quality.

• Collaborate with engineering, production, and quality assurance teams to develop and implement standard operating procedures (SOPs) and work instructions.

• Monitor and analyze process performance metrics, such as cycle time, yield and scrap rate and develop strategies to meet or exceed targets.

• Identify and implement process control measures, including statistical process control (SPC) techniques, to ensure consistent quality and reduce process variation.

• Provide technical support and troubleshooting expertise to resolve process-related issues and improve overall equipment effectiveness (OEE).

• Lead process validation activities, including protocol development, execution and documentation, ensuring compliance with regulatory requirements.

• Participate in cross-functional teams to drive root cause analysis, corrective actions, and preventive measures.

• Provide training and guidance to production teams on new processes, procedures, and equipment to ensure successful implementation and operation.

• Stay up to date with the latest advancements in process engineering technologies, methodologies, and best practices.

• Detail daily tasks involving the generation, processing, or storage of non-public data.

• Safeguard Federal Contract Information (FCI) and Controlled Unclassified Information (CUI) in accordance with FAR 52.204-21 and NIST SP 800-171 guidelines.

• Responsible for processing, labelling, and storing CUI-designated engineering and technical documents securely.

• Participate in mandatory annual security awareness training regarding the handling of sensitive government data and CMMC compliance.

Required skills and qualifications

• Strong knowledge of ISO 9001standards.

• Excellent leadership and team development skills.

• Experience with mechanical inspection and the use of equipment or tools used to perform mechanical inspection. i.e. gages, calipers, micrometers, testing meters and Coordinate Measuring Machine.

• Post-secondary education in a scientific, quality, manufacturing, or related field preferred.

• 3+ years’ experience in Quality Assurance within regulated manufacturing, medical, military or quality environment.

• 1–2 years of supervisory or leadership with team development skills

• Experience with audits, investigations, deviations, and quality documentation.

• Detail oriented with strong communication, problem-solving, and organizational skills, demonstrated through previous experience.