Torchora
Back to Home

Key Responsibilities and Required Skills for Operations Quality Engineer

💰 $ - $

QualityOperationsEngineering

🎯 Role Definition

The Operations Quality Engineer is responsible for driving product and process quality within manufacturing and operations environments. This role blends hands-on operational support with systems-level quality management—ensuring compliance with regulatory standards (e.g., ISO, FDA QSR, GMP), leading continuous improvement and corrective action programs (CAPA), and partnering cross-functionally to reduce defects, optimize process capability, and maintain customer satisfaction. The Operations Quality Engineer translates data into corrective and preventive actions, supports supplier quality and incoming inspection, and embeds robust quality practices into day-to-day operations.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Quality Engineer / Quality Assurance Associate
  • Manufacturing Engineer / Process Engineer
  • Supplier Quality or Production Supervisor

Advancement To:

  • Senior Operations Quality Engineer
  • Quality Manager / Quality Systems Manager
  • Continuous Improvement Manager / Operational Excellence Lead

Lateral Moves:

  • Supplier Quality Engineer
  • Regulatory Affairs Specialist
  • Process Validation Engineer

Core Responsibilities

Primary Functions

  • Lead day-to-day quality assurance and quality control activities on the manufacturing floor by developing and executing inspection plans, sampling programs, and process control checklists to ensure product conformance and minimize customer escapes.
  • Own root cause analysis for complex or recurring nonconformances using structured problem-solving methods (5 Whys, Fishbone/Ishikawa, DMAIC) and coordinate multi-disciplinary teams to implement robust corrective and preventive actions (CAPA) that eliminate systemic faults.
  • Develop, implement, and maintain Quality Management System (QMS) documentation including Standard Operating Procedures (SOPs), work instructions, forms, and batch records to ensure regulatory compliance (ISO 9001, ISO 13485, FDA QSR, GMP as applicable).
  • Drive statistical process control (SPC) and process capability improvement programs by creating and monitoring control charts, calculating Cp/Cpk, and partnering with operations to stabilize processes and reduce variation.
  • Lead and execute internal audits and prepare for external/third-party/regulatory audits; track audit findings, close nonconformances, and verify effectiveness of remediation plans.
  • Manage change control and deviation processes: evaluate proposed changes for quality and compliance impact, lead technical reviews, and ensure timely implementation while mitigating risk to product quality.
  • Design and deliver quality training programs for operators and supervisors covering inspection criteria, defect recognition, root cause basics, and GMP/QMS requirements to increase first-pass yield and reduce rework.
  • Partner with Manufacturing Engineering to support new product introductions (NPI) and scale-ups by completing quality risk assessments, process validations, inspection method validations, and ensuring robust control plans are in place.
  • Conduct supplier quality management activities including supplier selection support, supplier audits, incoming inspection criteria, performance monitoring (PPM), and supplier corrective action management.
  • Manage customer complaints and field quality issues end-to-end: lead investigation, containment, root cause, CAPA, and customer communications while maintaining traceability and evidence for regulatory purposes.
  • Implement and manage quality metrics and KPIs (yield, scrap, first-pass yield, PPM, CAPA closure time) and deliver weekly/monthly quality performance reports to operations and leadership to support data-driven decision-making.
  • Facilitate Failure Modes and Effects Analysis (FMEA) for products and processes; identify critical failure modes, prioritize mitigations, and integrate control measures into production processes.
  • Oversee metrology, calibration and measurement system analysis (MSA) programs to ensure measurement reliability and instrument traceability across inspection equipment and test fixtures.
  • Support engineering change orders (ECOs) and material changes by evaluating quality impact, updating documentation, and validating changes through pilot runs and post-change monitoring.
  • Apply Lean and Six Sigma methodologies to plan and execute continuous improvement projects (Kaizen events, 5S, root cause elimination) that reduce waste, lower costs, and improve product quality and throughput.
  • Collaborate with cross-functional teams (product management, R&D, operations, supply chain, regulatory) to ensure quality requirements are integrated across the product lifecycle and that risk is managed proactively.
  • Drive inspection automation and test method improvements by specifying test requirements, validating new fixtures/testers, and integrating automated data collection for real-time quality monitoring.
  • Ensure compliance with environmental, health, and safety (EHS) quality-related requirements and support investigations that intersect product quality and workplace safety issues.
  • Maintain traceability and documentation control for all quality records, including batch records, inspection data, and audit evidence to support regulatory submissions and customer audits.
  • Coordinate containment activities and interim controls for production when nonconforming product is discovered: quarantine, rework protocols, disposition, and communication to stakeholders.
  • Manage cross-site quality initiatives where applicable, harmonizing standards and best practices across multiple manufacturing locations to drive consistent quality performance.
  • Analyze warranty, returns, and field failure data using statistical tools and translate findings into prioritized corrective action plans that reduce recurrence and warranty cost.
  • Support digital quality tools and ERP/QMS integrations (e.g., SAP QM, MasterControl, TrackWise, Jira) to improve traceability, data integrity, and audit readiness.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis.
  • Contribute to the organization's data strategy and roadmap.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.
  • Serve as a subject matter expert for quality topics during cross-functional program reviews and product roadmap planning.
  • Mentor junior quality staff and provide coaching on investigation methodologies and quality best practices.

Required Skills & Competencies

Hard Skills (Technical)

  • Proven expertise in Quality Management Systems (QMS) such as ISO 9001, ISO 13485, or equivalent.
  • Strong knowledge of regulated manufacturing requirements: GMP, FDA Quality System Regulation (QSR), medical device or pharmaceutical quality standards (if applicable).
  • Root cause analysis & CAPA management: 8D, 5 Whys, Fishbone, DMAIC.
  • Statistical Process Control (SPC), process capability analysis (Cp/Cpk), and measurement system analysis (MSA).
  • Failure Mode and Effects Analysis (FMEA), risk assessment and mitigation planning.
  • Experience with quality tools: Minitab, JMP, or equivalent statistical software.
  • Hands-on experience with ERP/QMS platforms: SAP QM, MasterControl, TrackWise, or similar.
  • Data analysis and reporting: advanced Excel (pivot tables, macros), SQL query skills, and familiarity with data visualization tools (Tableau, Power BI).
  • Knowledge of APQP, PPAP, and production part approval process or equivalent for supplier/production validation.
  • Experience conducting supplier and vendor audits, supplier scorecarding, and supplier corrective actions.
  • Process validation and qualification experience for new product introduction and scale-up activities.
  • Familiarity with metrology, calibration programs and inspection equipment qualification.
  • Practical experience with Lean Manufacturing and Six Sigma methodologies; Green/Black Belt certification preferred.
  • Strong documentation control practices, including SOP authoring, change control, and audit evidence preparation.

Soft Skills

  • Strong analytical and problem-solving skills with an aptitude for data-driven decision making.
  • Excellent verbal and written communication; able to translate technical quality concepts to non-technical stakeholders.
  • Leadership and cross-functional influencing: ability to lead projects without direct authority and build consensus.
  • High attention to detail with strong organizational skills and ability to manage competing priorities.
  • Customer-focused mindset with commitment to continuous improvement and delivering measurable results.
  • Time management and project management capabilities: ability to drive projects to timely closure.
  • Adaptability and resilience in fast-paced, regulated environments.
  • Coaching and mentoring skills to develop junior team members and embed quality culture.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in Engineering, Quality, Industrial Engineering, Manufacturing, Chemistry, Biology, or related technical discipline.

Preferred Education:

  • Master's degree in Engineering, Quality, or Business Administration (MBA) preferred.
  • Professional certifications such as Certified Quality Engineer (CQE), ASQ, Six Sigma Green/Black Belt, or Certified Manager of Quality/Organizational Excellence (CMQ/OE) are strongly preferred.

Relevant Fields of Study:

  • Industrial Engineering
  • Mechanical Engineering
  • Biomedical / Biological Sciences
  • Chemical Engineering / Chemistry
  • Manufacturing Engineering
  • Quality Assurance & Regulatory Affairs

Experience Requirements

Typical Experience Range: 3–7 years of hands-on quality experience in manufacturing or operations; 5+ years preferred for mid-senior roles.

Preferred:

  • 5+ years in regulated industries (medical devices, pharmaceuticals, aerospace, automotive, consumer electronics) with demonstrated success in CAPA, audits, and cross-functional project leadership.
  • Proven track record of implementing process controls, reducing defect rates, leading audits, and delivering measurable quality improvements.
Explore More Careers