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I’d put the Quality Manager in charge of the QMS and the Quality Engineer in charge of production controls - with top management accountable for both. Before launch, confirm that AS9100 applies, then name who can stop work, hold material, approve dispositions, and release product.
My hiring rule is simple: hire the manager first if no one owns the QMS; hire the engineer first if system oversight exists but floor controls are weak. Hire both when system setup and high-risk production must start together.
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I’d tie each launch task to a named owner, deadline, and approval authority. For certification preparation, plan one full internal QMS audit and one management review, then address findings and check the fixes.
The test is simple: Can your team show that the controls work? <u>Job titles and signed procedures alone aren’t enough.</u>
Quality Engineer vs Quality Manager: AS9100 Startup Roles
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Assign responsibilities by process, not job title. On a new factory floor, this keeps system ownership and day-to-day line work from falling through the cracks. Use the matrix below to shape job descriptions and your hiring and workforce plan. “Owns” means accountability for the process - not authority over every technical approval.
Assign these duties to named process owners. Purchasing, Engineering, Operations, and supervisors retain authority within their functions. Quality coordinates the work and verifies that it meets requirements.
The manager sets the QMS boundaries, works with leadership on policy and measurable objectives, and confirms who owns each process. The role also owns document control, audit scheduling, management review inputs, and escalation. Keep auditors independent: the Quality Engineer should not audit their own controls.
Authority must go beyond asking for fixes. Give the manager direct access to leadership, authority to contain suspect product, and a clear path to secure corrective-action resources. Define the engineer’s product-hold authority separately. Disposition decisions must follow documented authority and customer requirements.
Once ownership is clear, translate those responsibilities into procedures and inspection controls.
The engineer translates drawings, tolerances, and customer requirements into inspection plans, acceptance criteria, reaction plans, and production records. This work includes measurement methods, calibration controls, risk analysis, and statistical tools when needed.
When AS9102 applies, plan FAI before the first production run and link every design characteristic to objective evidence. When defects occur, the engineer investigates causes and checks whether the corrective action worked. The responsible department implements the fix.
Before launch, put these controls into procedures, training, supplier rules, and nonconformance records.
Give every deliverable a named owner, due date, and approval authority in the launch schedule. The launch team resolves staffing, equipment, and schedule gaps. It does not override technical approvals.
Keep manufacturing readiness separate from construction turnover and equipment commissioning. Use the assignments below as a starting point, document delegated authority in the QMS, and turn that role split into named launch deliverables.
The Quality Manager controls document numbering, revision status, review, approval, access, removal of obsolete documents, retention, and change history. The Quality Engineer develops the technical content. Production and engineering should check that released documents work on the floor.
Release only revision-controlled instructions, and link training to the revision used. Records should connect supplier certificates, material heat or lot numbers, production travelers, inspection results, and final acceptance. Before launch, test whether records can be retrieved across that chain and document any missing links. Set retention periods according to applicable customer, contract, statutory, and QMS requirements - not an assumed universal period.[5][7]
Commissioning records prove only installation and equipment acceptance. Keep them separate from production, training, and traceability records.
With records under control, supplier approval becomes the next release gate.
At startup, the Quality Manager applies supplier approval criteria, monitoring frequency, suspension rules, and escalation thresholds. Purchasing includes applicable drawing revisions, certification, traceability, change-notification, and subtier requirements in purchase orders.
The Quality Engineer checks technical capability, sets receiving controls, and supports supplier corrective actions with Engineering. For heat treating, welding, plating, or nondestructive testing, verify required source approvals, personnel qualifications, and process records before release. Track quality and on-time delivery. Do not release work until all required qualifications and records are complete.[3][7][8]
If a supplier defect escapes, move immediately to containment and disposition.
Production and the Quality Engineer first stop unintended use or shipment, segregate suspect material, and identify affected lots or the process window. Before seeking disposition, record the requirement, actual condition, quantity, and containment.
Neither title grants unrestricted acceptance authority. Repair, use-as-is, or deviations must follow delegated authority and any required customer or design-authority approvals.
The Quality Engineer leads root-cause analysis, the process owner implements the fix, and the Quality Manager controls escalation and closure. Verify reworked product separately from corrective-action effectiveness: a corrected part does not prove the problem won't recur.[5][6]
Once startup controls are running, the system must be ready for a certification audit. The Quality Manager owns audit readiness; the Quality Engineer shows that the production floor can produce compliant records.
Define scope before setting the audit date. Identify the covered sites, products, processes, outsourced work, and applicable customer-specific, statutory, and regulatory requirements. Map them to AS9100, then run the processes in production to generate records. Before certification, complete one full internal audit of the QMS and one management review, resolve findings, and verify that corrective actions worked.[10][13][18] This division keeps management accountable for readiness and the floor accountable for execution.
The Quality Manager owns the readiness plan, requirements-to-process matrix, competence-record checks, and corrective-action tracking. Work early with an accredited certification body to agree on scope, production availability, required records, and audit timing. Stage 1 checks readiness; Stage 2 checks implementation and effectiveness.[14][17]
Internal audits must cover every applicable QMS process and requirement. Use qualified, objective and impartial auditors - not people auditing their own work. The manager prepares the management-review inputs, but top management conducts the review. Inputs must include audit results, customer feedback, process performance and product conformity, supplier performance, risks, resource needs, and corrective-action status. Record leadership’s decisions, action owners, and due dates.[9][11][13]
The Quality Engineer makes records easy to retrieve by work order, part number, revision, and lot or serial number. Inspection results must connect acceptance criteria to measured results. Calibration records must establish the equipment’s status when it was used. Include traceability records, applicable AS9102 first article packages, and supplier approval and certification records. Signed procedures alone do not prove implementation. Corrective-action records must show that the fix worked - not just that someone signed off on an action.[12][15][16]
Before confirming audit readiness, sample recent work orders from requirements through shipment. Check that each in-scope process has both records showing it is in use and internal-audit coverage. If production history is limited, agree on evidence expectations with the certification body. Guidance may request 12 months of trend data, but that is not a universal waiting period.[12][13][19]
Hire for the biggest gap in local controls: QMS ownership, production controls, or both. The launch risk should determine which role starts first.
For AS9100 implementation, that means checking who owns the system on the new floor and whether the site can produce controlled output and audit-ready evidence. Base the hiring order on the site’s current controls - not its org chart.[4][6]
Corporate procedures do not replace local ownership.[6][20][21] Without a local owner, the first hire must establish system control before execution can scale.
Hire the manager first when no one owns implementation, audit coordination, or escalation.[23][6] Look for AS9100 implementation experience, management review, and corrective-action governance - not just inspection oversight.
Ask candidates how they took a site from informal practices to an auditable system. Have them explain how they secured leadership decisions and resources along the way.[21][22][23]
When QMS oversight is already in place, the first hire should stabilize production controls and evidence. Hire the engineer first when corporate quality covers the site, but production lacks inspection methods, process controls, measurement capability, or AS9102 support.[6][24]
Look for manufacturing process knowledge and proof that candidates have solved recurring defects by improving controls.[25] Hire both before launch when QMS development and industrialization of high-risk products must happen in parallel.[24][6]
Write job descriptions that spell out reporting lines, decision rights, launch deliverables, and stop-work authority.[4][6]
Yes, one person can handle both roles, depending on the size of your business. Smaller startups often combine them. Most plants with 150 or more employees, however, need a Quality Manager to oversee the system and Quality Engineers to manage product-line controls.
For AS9100 registration, formally name the person handling both roles as the management representative. This keeps organizational accountability clear for the quality management system, audit readiness, and corrective action governance.
No. AS9100 certification applies to organizations and their quality management systems - not the physical building [1]. The facility’s layout, clean zones, and environmental controls must still support production quality.
At turnover, commissioning records, calibration data, and a validation-ready turnover package verify that the facility meets the requirements the organization needs to maintain its AS9100 registration [1].
Prevent conflicts by clearly separating responsibilities and authority. The Quality Manager owns the plant’s quality management system, including AS9100 registration, audit readiness, MRB authority, and CAPA governance. They have final authority over system integrity [1].
The Quality Engineer handles process controls, inspection methods, and nonconformance investigations for specific product lines. Their role is to keep production processes within established control limits [1][2]. This division supports independent oversight that protects deliveries and compliance [1].
