Quality Control & Process Manager

The Quality Control & Process Manager is responsible for building, implementing, and managing the company’s quality control system from the ground up. This position will establish the processes, procedures, documentation, inspection standards, and accountability necessary to create a consistent and effective quality system across the organization.

The position is responsible for developing and maintaining quality systems and processes that ensure incoming materials, fabricated parts, assembly operations, kitting processes, in-process manufacturing, and finished products meet company, customer, and applicable regulatory requirements.

The role oversees all quality control activities across manufacturing and shipping operations, including the development and implementation of QC processes for fabrication, assembly, kitting, and finished products. Responsibilities include documentation control, non-conformance management, root cause analysis, corrective and preventive action (CAPA), supplier quality, and continuous improvement.

The successful candidate must be capable of taking ownership of the quality function and building a structured QC system where one does not currently exist. This includes assessing current practices, identifying gaps and documentation requirements, creating procedures and standards, implementing systems, training personnel, and ensuring consistent execution across departments.

The quality system should go beyond simply meeting minimum regulatory, customer, and industry requirements. Ensuring error free shipments is the baseline: the objective is to establish processes and standards that consistently deliver high-quality, reliable products. This may include standards for workmanship, appearance, fit, finish, consistency, and other aspects of overall product quality where appropriate.

The position requires strong attention to detail, analytical ability, technical and mechanical aptitude, and the ability to work cross-functionally in a fast-paced, high-mix, low-volume manufacturing environment.

• Build the company’s QC system from the ground up, including processes, procedures, requirements, documentation, records, and accountability.
• Assess current manufacturing quality practices, identify gaps, and establish standardized quality processes.
• Document current manufacturing processes, workflows, and procedures.
• Develop, implement, and maintain QC processes for fabrication, assembly, kitting, in-process manufacturing, and finished products.
• Work with Manufacturing Engineering to help improve incoming inspection requirements, develop inspection standards, inspection points, acceptance criteria, and documentation requirements.
• Establish and maintain the in-process, and final inspection processes.
• Create and maintain quality control documentation, reports, procedures, work instructions, and standards across departments.
• Develop and maintain document control processes to ensure quality documentation is accurate, current, accessible, and properly controlled.
• Ensure compliance with internal quality standards, customer specifications, engineering requirements, and applicable regulatory requirements.
• Establish quality standards and processes that go beyond minimum regulatory and customer requirements, with a focus on efficiency, and overall product quality, consistency, and reliability.
• Establish appropriate standards for workmanship, appearance, fit, finish, and other quality characteristics not fully defined by drawings or specifications.
• Manage and maintain the company Quality Management System (QMS).
• Establish and maintain systems for tracking and analyzing quality performance and trends.
• Manage and maintain Non-Conformance Reports (NCRs) and related…