Quality Systems Manager

GTI Fabrication

$105K — $125K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in quality, engineering, business, operations or a related discipline, or equivalent relevant experience.
  • At least five years in manufacturing quality management, including two years leading QMS implementations.
  • Experience with ISO 9001 QMS implementation and external certification audits.
  • Formal ISO 9001 internal-auditor training; skilled in root-cause analysis and document control.
  • Ability to influence stakeholders and manage competing priorities based on objective evidence.
  • Proficiency with Microsoft 365 and document-control platforms.

Responsibilities

  • Own site quality management system (QMS) governance and process interactions.
  • Lead ISO 9001 certification preparations and audits; maintain readiness through evidence collection.
  • Develop an internal audit program; ensure effective corrective actions from audit findings.
  • Administer document control processes to ensure current procedures are accessible.
  • Coordinate management reviews to consolidate performance and improvement opportunities.
  • Manage the corrective-action system utilizing 8D methodology for effective resolutions.
  • Maintain QMS training and competency requirements in collaboration with HR.

Benefits

  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid Time Off (PTO) and paid holidays
  • Sick time according to state and local regulations
  • Company-paid life insurance and disability coverage
  • Career advancement opportunities in a growing organization
  • Exposure to advanced manufacturing and large-scale projects
  • Collaborative, fast-paced environment with a focus on safety and continuous improvement.
Full Job Description
Position Overview

Lead the development, implementation and continual improvement of the Goodyear quality management system (QMS), aligned with ISO 9001 and GTI corporate requirements. Establish practical processes that support consistent execution, objective evidence, effective corrective action and sustained certification readiness as the facility scales. When authorized, lead integration of quality, occupational health and safety, and environmental management systems in partnership with EHS and corporate process owners.
Key Responsibilities
  • Own site QMS governance, including scope, process interactions, documented information, risks and opportunities, objectives, change planning and alignment with the corporate management system. Guide process owners in establishing and maintaining effective controls.
  • Lead ISO 9001 certification preparation, surveillance and recertification activities. Serve as the site coordinator for the certification body and management-system audits; maintain readiness through routine execution and evidence.
  • Develop and execute a risk-based internal audit program covering applicable processes and shifts. Qualify auditors, preserve audit objectivity and impartiality, and verify that findings result in effective corrective action.
  • Administer document and record control, including approval, revision, access, retention and obsolete-document prevention. Work with Engineering and Operations to ensure current drawings, procedures and instructions are available at the point of use.
  • Coordinate management reviews: consolidate performance, audit results, customer feedback, risks, resource needs and improvement opportunities; document decisions, owners and follow-through.
  • Own the corrective-action system and 8D methodology: establish intake, risk-based escalation, ownership, due dates and closure criteria. Challenge unsupported root causes and verify sustained effectiveness; accountable process owners implement corrective actions.
  • Maintain QMS training and competency requirements with HR and department leaders. Coordinate system training, retain evidence and assess effectiveness; supervisors remain responsible for employee qualification and job performance.
  • Maintain governance for calibration, site inspection and measurement equipment readiness, calibration status and suitability. Coordinate measurement-system analysis where appropriate;
  • Define reliable system metrics and reporting methods. Analyze recurring findings, overdue actions and cross-functional trends, and facilitate improvements that prevent recurrence across products, shifts and processes.
  • Lead assigned systems personnel through clear objectives, coaching, development and performance management. Plan system resources and promote factual communication, timely escalation and accountability consistent with GTI values.
Potential integrated management system scope

If GTI approves an integrated management system (IMS), coordinate gap assessment and implementation planning for ISO 14001 and ISO 45001, as applicable. Integrate document control, audits, management review, objectives, competency records and corrective action. Partner with EHS on environmental aspects, hazard and risk assessments, compliance obligations, emergency preparedness, and worker consultation and participation.

EHS retains technical ownership of safety and environmental programs, legal-compliance determinations and required regulatory reporting unless separately assigned. This position coordinates the management-system framework; expansion of scope requires agreed responsibilities, competence and resources.
Authority and working relationships

Require adequate evidence before closing system findings; reject incomplete corrective-action submissions; escalate systemic risks, missed commitments and certification threats to global Quality leadership. Initiate containment or request suspension of an affected activity when a serious control failure is identified, consistent with GTI escalation procedures. This role does not independently waive customer, statutory or regulatory requirements or release nonconforming product.

Partner with Production Quality, Operations, Engineering, EHS, HR, Supply Chain and corporate Quality. Process owners remain accountable for their processes; the Quality Systems Manager establishes governance and evaluates effectiveness.

Required qualifications
  • Bachelor's degree in quality, engineering, business, operations or a related discipline, or an equivalent combination of relevant education and experience.
  • At least five years of progressive manufacturing quality or management-system experience, including two years leading QMS implementation, audits or cross-functional system improvement.
  • Demonstrated experience implementing or maintaining an ISO 9001 QMS and supporting successful external certification audits. Ability to translate requirements into practical manufacturing controls.
  • Formal ISO 9001 internal-auditor training and demonstrated audit leadership; proficiency in root-cause analysis, corrective action, process mapping, document control and management review.
  • Ability to influence process owners, resolve ownership gaps, communicate findings clearly and manage competing priorities using objective evidence.
  • Proficiency with Microsoft 365 and electronic document-control or QMS platforms; ability to analyze data and maintain accurate, traceable records.
Preferred qualifications
  • ISO 9001 lead-auditor training or certification; ASQ Certified Manager of Quality/Organizational Excellence, Certified Quality Auditor, or comparable credential.
  • Experience integrating ISO 14001 and ISO 45001 systems, including coordination with qualified EHS professionals.
  • Experience in a rapidly scaling manufacturing facility, multisite QMS deployment, Lean Six Sigma, ERP-based records or digital workflow improvement.
Measures of success

Sustained audit readiness and certification milestones; internal audit completion and coverage; reduction in repeat findings; timely, evidence-based corrective-action closure with verified effectiveness; current controlled documents at point of use; completed management-review actions; and demonstrated training effectiveness. Targets are established with leadership based on baseline performance and risk.
Work environment and essential capabilities

Primarily onsite in Goodyear, Arizona, with regular presence in manufacturing areas and coordination across shifts. Requires reviewing records, conducting audits, facilitating meetings and communicating with employees and external auditors. Occasional travel and schedule flexibility may be required. Follow site PPE and safety requirements. Essential functions may be performed with reasonable accommodation.

$105,000 - $125,000 a year

Perks & Benefits

GTI offers a competitive compensation and benefits package designed to support employees and their families while providing long-term career growth opportunities within a fast-growing manufacturing organization. Benefits may include:
  • Medical, dental, and vision insurance
  • 401(k) with company match (where applicable)
  • Paid Time Off (PTO) and paid holidays
  • Sick time in accordance with state and local requirements
  • Company-paid life insurance and disability coverage
  • Career advancement opportunities within a rapidly growing organization
  • Exposure to advanced manufacturing, modular infrastructure, and large-scale industrial projects
  • Collaborative, fast-paced environment with strong operational and engineering leadership
  • Employee-focused culture centered on safety, quality, accountability, and continuous improvement

Benefits eligibility and offerings may vary based on position, location, and employment classification.

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