Key Responsibilities and Required Skills for Quality Officer

🎯 Role Definition

As our new Quality Officer, you will be the cornerstone of our quality assurance framework. You will be instrumental in developing, implementing, and maintaining robust quality control processes and systems across the organization. This position requires a meticulous professional who can ensure our products, services, and internal processes not only meet but exceed industry standards and customer expectations. You will collaborate cross-functionally with production, engineering, and supply chain teams to embed a culture of quality, investigate non-conformances, and champion corrective actions that enhance operational efficiency and product integrity.

📈 Career Progression

Typical Career Path

Entry Point From:

Quality Technician
QA Inspector
Compliance Coordinator

Advancement To:

Senior Quality Officer
Quality Manager
Head of Quality Assurance

Lateral Moves:

Process Improvement Specialist
Regulatory Affairs Specialist

Core Responsibilities

Primary Functions

Develop, implement, and meticulously maintain the company's Quality Management System (QMS) to ensure ongoing compliance with ISO 9001 and other relevant industry standards.
Conduct and lead comprehensive internal and supplier audits to assess compliance with quality standards, regulations, and contractual requirements, preparing detailed audit reports and driving follow-up actions.
Spearhead root cause analysis investigations for non-conformances, customer complaints, and internal process failures using structured methodologies like 5 Whys, Fishbone diagrams, or 8D.
Manage the end-to-end Corrective and Preventive Action (CAPA) program, ensuring timely documentation, implementation, and rigorous verification of the effectiveness of all actions taken.
Monitor, analyze, and report on key quality performance indicators (KPIs) to senior management, identifying adverse trends and recommending strategic, data-driven improvements.
Facilitate and prepare for management review meetings by compiling critical quality data, presenting performance metrics, and meticulously documenting minutes and resulting action items.
Oversee the entire document control system, ensuring that all quality-related policies, procedures, work instructions, and records are current, accurate, and readily accessible to authorized personnel.
Collaborate closely with product development and engineering teams to establish and integrate quality requirements for new products and processes, actively participating in design reviews and risk assessments (FMEA).
Champion a pervasive culture of continuous improvement by promoting quality awareness and delivering effective training to employees on quality standards, procedures, and essential tools.
Manage the calibration and maintenance schedule for all inspection, measuring, and test equipment to guarantee measurement accuracy, precision, and reliability.
Review and approve complex validation protocols (IQ/OQ/PQ) and reports for new equipment, processes, and systems to ensure they meet predefined specifications and regulatory requirements.
Serve as a primary and knowledgeable point of contact for external auditors, regulatory agencies, and customer quality representatives during inspections, audits, and formal inquiries.
Evaluate and monitor supplier quality performance, participate in the supplier qualification and approval process, and partner with suppliers to resolve quality issues and drive systemic improvements.
Coordinate the inspection and testing protocols for incoming raw materials, in-process components, and finished products to ensure they consistently conform to all technical specifications.
Develop, refine, and maintain detailed product specifications and quality standards, ensuring they are clearly defined and effectively communicated throughout the organization.
Thoroughly investigate and resolve customer complaints in a timely and professional manner, guaranteeing that containment, correction, and robust preventive measures are effectively implemented.
Author and revise Standard Operating Procedures (SOPs), work instructions, and quality manuals to reflect current best practices, process changes, and evolving regulatory landscapes.
Proactively perform and document risk assessments on critical processes and products to identify potential quality failures and implement effective mitigation strategies before they occur.
Drive the tangible reduction of waste, rework, and scrap by identifying process inefficiencies and collaborating with operational teams on high-impact Lean or Six Sigma improvement projects.
Ensure all activities related to final product release are completed in strict accordance with established procedures, including final batch record review and formal approval.
Support the implementation of statistical process control (SPC) techniques to monitor process capability and stability, championing data-based decision-making on the production floor.
Maintain an up-to-date and expert-level knowledge of applicable local, national, and international regulations and standards relevant to the company's specific industry sector.

Secondary Functions

Support cross-functional teams with ad-hoc quality data requests and exploratory analysis to identify improvement opportunities.
Contribute to the strategic planning and evolution of the organization's long-term quality roadmap and objectives.
Collaborate with business units to translate operational needs and customer feedback into tangible quality system requirements.
Participate in agile project teams and departmental meetings to provide quality assurance input and ensure compliance throughout project lifecycles.

Required Skills & Competencies

Hard Skills (Technical)

Deep proficiency with Quality Management Systems (QMS) and principles (e.g., ISO 9001, AS9100, IATF 16949, or ISO 13485).
In-depth knowledge of core quality assurance methodologies, including CAPA, root cause analysis, FMEA, and risk management.
Proven experience conducting internal and external quality audits and managing audit findings from identification through to final resolution.
Strong understanding of document control and records management principles within a regulated and structured environment.
Competency in using statistical analysis tools (e.g., Minitab, JMP) and applying Statistical Process Control (SPC) to manufacturing or business processes.
Familiarity with metrology principles, including the management of calibration programs for inspection, measurement, and test equipment (IM&TE).

Soft Skills

Exceptional attention to detail and meticulous organizational and planning skills.
Powerful analytical and problem-solving abilities with a proven, data-driven mindset.
Excellent verbal and written communication skills, with the ability to author clear technical reports and present complex information to diverse audiences.
Strong interpersonal and collaboration skills to effectively work with cross-functional teams and influence stakeholders without direct authority.
A proactive, self-motivated work ethic with the ability to manage multiple competing priorities in a dynamic, fast-paced environment.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree

Preferred Education:

Master's degree or professional certifications (e.g., ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Six Sigma Green/Black Belt).

Relevant Fields of Study:

Engineering (Industrial, Mechanical, Chemical)
Life Sciences (Biology, Chemistry)
Business Administration or Quality Management

Experience Requirements

Typical Experience Range:

3-5 years of direct experience in a quality assurance or quality control role.

Preferred:

Experience within a highly regulated industry such as manufacturing, pharmaceuticals, medical devices, automotive, or aerospace is highly preferred.