Quality Assurance Manager

SUMMARY

The Quality Assurance Manager is responsible for ensuring consistent product quality by developing and enforcing best manufacturing practices, validating processes, maintaining documentation, and leading quality staff. The role oversees the development, implementation, and continuous improvement of a Quality Management System (QMS) that meets customer, regulatory, and industry requirements. This includes monitoring performance metrics, driving corrective actions, and promoting a culture of quality across the organization.

KEY RESPONSIBILITIES

Quality Management System (QMS) Leadership

• Serve as the Management Representative for ISO 9001, ISO 13485, and AS9100.
• Maintain and improve the organization’s certified QMS.
• Report QMS performance and improvement initiatives to executive leadership.
• Promote awareness of customer requirements, quality objectives, and QMS performance.

Quality Operations

• Oversee incoming, in‑process, and final product inspections.
• Supervise a team of quality inspectors and quality support staff.
• Manage nonconforming material processes and major supplier or internal quality issues.
• Lead corrective and preventive action (CAPA) activities.
• Oversee calibration programs and equipment compliance.
• Maintain documentation control for all QMS forms, procedures, and work instructions.
• Coordinate customer-required quality surveys and questionnaires.

Auditing & Reporting

• Conduct and supervise internal audits.
• Prepare and publish quality performance reports (e.g., scrap, on‑time delivery, RMA trends).
• Facilitate management reviews and ensure follow‑up on action items.

Training & Continuous Improvement

• Lead training sessions for inspectors and support company‑wide quality training initiatives.
• Implement programs to improve quality performance, efficiency, and compliance.
• Support cross‑training and continuous improvement activities.

Authority

• Stop production or shipment when quality risks are identified.
• Direct and prioritize the work of quality inspectors.
• Issue verbal or written warnings related to QMS compliance.

Additional Duties

• Review bills of materials (BOMs) as needed.
• Provide guidance to inventory control teams.

Competencies

• Strong understanding of quality management systems and regulatory standards.
• Knowledge of lean manufacturing, Six Sigma, 6S, Kaizen, and continuous improvement tools.
• Skilled in problem‑solving and design for manufacturability.
• Strong communication, leadership, and organizational abilities.
• Ability to build and lead a high‑performance team.
• Experience with electrical measurements and inspection tools.
• Familiarity with calibration, tolerances, FMEA, control plans, and PDCA methodologies.

Supervisory Responsibilities

• Hire, train, and develop quality assurance staff.
• Oversee daily workflow and scheduling.
• Conduct performance evaluations.
• Manage disciplinary actions in accordance with company policy.

REQUIRED EDUCATION & EXPERIENCE

• Bachelor’s degree in business, engineering, materials science, or a related technical field.
• 3+ years managing ISO 9001, ISO 13485, and/or AS9100 QMS environments.
• Experience with UL/CSA requirements and audits.
• 2+ years in a supervisory or management role.
• Experience with conflict resolution and change management.
• Ability to read schematics, drawings, and blueprints.
• Strong computer skills, including ERP systems, Microsoft Office, and Adobe tools.

PREFERRED QUALIFICATIONS

• Experience in flexible heater, flex circuit, or similar manufacturing environments.
• Basic electrical knowledge.
• Certifications such as CQA, CQE, Six Sigma Black Belt, SPC/Minitab, or Continuous Improvement Champion.