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Key Responsibilities and Required Skills for Quality Systems Engineer

💰 $85,000 - $125,000

EngineeringQuality AssuranceManufacturingComplianceAerospace & DefenseMedical DevicesAutomotive

🎯 Role Definition

As a Quality Systems Engineer, you are the architect and guardian of our organization's commitment to excellence. You will be instrumental in developing, implementing, and maintaining our Quality Management System (QMS) to ensure our products and processes not only meet but exceed customer expectations and rigorous regulatory standards. This role is a dynamic blend of technical expertise, strategic thinking, and cross-functional leadership, placing you at the heart of our continuous improvement culture. You will be the subject matter expert on quality standards (such as ISO 9001, AS9100, or ISO 13485), driving compliance and efficiency throughout the entire product lifecycle.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Quality Engineer or Technician
  • Process Engineer
  • Manufacturing Engineer
  • Junior Internal Auditor

Advancement To:

  • Senior Quality Systems Engineer
  • Quality Assurance Manager
  • Director of Quality or Compliance
  • Continuous Improvement Manager

Lateral Moves:

  • Supplier Quality Engineer
  • Regulatory Affairs Specialist
  • Operations or Production Manager

Core Responsibilities

Primary Functions

  • Develop, implement, and meticulously maintain the company's Quality Management System (QMS) to ensure robust compliance with ISO 9001, AS9100, IATF 16949, ISO 13485, and/or other applicable industry and customer-specific requirements.
  • Lead and serve as the primary point of contact for internal, external, customer, and third-party registration audits, ensuring successful outcomes and timely closure of any findings.
  • Manage the end-to-end Corrective and Preventive Action (CAPA) system, facilitating cross-functional teams to conduct thorough root cause analysis (RCA) and implement effective, sustainable solutions.
  • Administer the document and data control system, ensuring all quality manuals, procedures, work instructions, and records are properly created, revised, reviewed, and controlled.
  • Drive the Management Review process by collecting, analyzing, and presenting key QMS performance metrics and trends to the executive leadership team to inform strategic decision-making.
  • Act as the subject matter expert for all QMS-related matters, providing guidance and interpretation of standards and regulations to all departments within the organization.
  • Champion continuous improvement initiatives across the organization by applying Lean Manufacturing, Six Sigma, and other problem-solving methodologies to enhance process stability, reduce waste, and improve product quality.
  • Oversee and manage the internal audit program, including creating the audit schedule, training auditors, conducting process audits, and tracking the effectiveness of corrective actions on audit findings.
  • Collaborate closely with Engineering and R&D teams during New Product Introduction (NPI) to ensure that all quality system requirements, risk assessments (like FMEA), and customer specifications are met from design to launch.
  • Investigate complex internal and external quality issues, including customer complaints and significant non-conformances, ensuring a systematic approach to problem resolution and communication.
  • Manage the supplier quality function by participating in supplier selection and qualification, monitoring supplier performance, and conducting supplier audits to ensure the integrity of the supply chain.
  • Develop, monitor, and report on Key Performance Indicators (KPIs) for the quality system, such as Cost of Poor Quality (COPQ), First Pass Yield (FPY), and On-Time Delivery (OTD).
  • Direct the disposition of non-conforming materials and products through the Material Review Board (MRB) process, ensuring proper documentation and segregation.
  • Lead risk management activities, including the creation, review, and maintenance of Process Failure Mode and Effects Analysis (PFMEA) documents to proactively identify and mitigate potential process failures.
  • Ensure the calibration and maintenance program for all measurement and test equipment is effective, compliant, and maintains traceability to recognized standards.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis to uncover hidden trends in production, supplier, and quality data.
  • Develop and deliver targeted QMS and compliance training to personnel at all levels, fostering a deep-rooted culture of quality and accountability.
  • Mentor junior engineers and quality technicians on QMS principles, auditing techniques, and root cause analysis methodologies.
  • Evaluate, recommend, and assist in the implementation of new quality software and digital tools (e.g., eQMS, SPC software) to modernize and streamline quality processes.
  • Participate in and provide quality systems input for customer and project-specific quality plans to ensure all contractual requirements are understood and met.
  • Collaborate with business units to translate data needs into engineering requirements for reporting dashboards and analytics.
  • Participate in sprint planning and agile ceremonies within the data engineering team if applicable to the role's data analysis functions.

Required Skills & Competencies

Hard Skills (Technical)

  • QMS Standards Expertise: Deep, practical knowledge of quality management systems such as ISO 9001, AS9100, IATF 16949, or ISO 13485.
  • Auditing Proficiency: Certified Internal or Lead Auditor (e.g., ASQ CQA) with hands-on experience planning, conducting, and reporting on audits.
  • Root Cause Analysis (RCA): Mastery of structured problem-solving methodologies including 8D, 5 Whys, Fishbone (Ishikawa) diagrams, and Fault Tree Analysis.
  • Statistical Analysis: Proficiency in Statistical Process Control (SPC), capability analysis (Cpk, Ppk), and Gage R&R using software like Minitab or JMP.
  • Continuous Improvement Methodologies: Experience with Lean principles, and preferably a Six Sigma Green Belt or Black Belt certification.
  • Risk Management: Proven ability to lead and facilitate risk assessments using tools like FMEA (Failure Mode and Effects Analysis) and Control Plans.
  • CAPA Management: Experience managing a Corrective and Preventive Action (CAPA) system from initiation to verification of effectiveness.
  • Technical Documentation: Skill in writing, reviewing, and controlling technical documents, including procedures, work instructions, and quality manuals.
  • ERP/QMS Software: Familiarity with Enterprise Resource Planning (ERP) systems (e.g., SAP, Oracle) and electronic Quality Management System (eQMS) platforms.

Soft Skills

  • Analytical Problem-Solving: Ability to dissect complex problems, analyze data from multiple sources, and develop logical, effective solutions.
  • Communication & Interpersonal Skills: Excellent verbal and written communication skills, with the ability to articulate complex technical concepts to diverse audiences, from shop-floor operators to senior executives.
  • Cross-Functional Collaboration: A natural ability to build relationships and work effectively with teams in Engineering, Operations, Supply Chain, and Sales.
  • Meticulous Attention to Detail: An unwavering focus on accuracy and thoroughness in all aspects of work, from document review to data analysis.
  • Project Management: Strong organizational and time-management skills to manage multiple projects, audits, and CAPAs simultaneously.
  • Influence and Leadership: The capacity to lead by example and influence others without direct authority to drive a "quality-first" culture.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor of Science (B.S.) degree in a technical or engineering discipline.

Preferred Education:

  • Master of Science (M.S.) in Engineering, Quality Assurance, or Business Administration (MBA).
  • Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or Six Sigma Black Belt.

Relevant Fields of Study:

  • Industrial Engineering
  • Mechanical Engineering
  • Electrical Engineering
  • Manufacturing Engineering
  • Quality Management

Experience Requirements

Typical Experience Range: 3-7 years of direct experience in a quality engineering or quality systems role within a regulated manufacturing environment.

Preferred:

  • Experience in a highly regulated industry such as aerospace, medical device, automotive, or pharmaceuticals.
  • Proven track record of successfully leading a company through an ISO or other third-party certification audit.
  • Hands-on experience implementing a new QMS or significantly overhauling an existing one.
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