Senior Quality Engineer (Production)

Production Quality Controls & Manufacturing Readiness

• Lead and continuously improve quality controls across assigned manufacturing and microfabrication processes, ensuring alignment with approved procedures, work instructions, specifications, control plans, PFMEAs, risk controls and QMS requirements. Identify systemic risks and drive actions to improve process robustness, product quality and manufacturing readiness.
• Drive the implementation and maintenance of production controls, including line clearance, contamination control, environmental conditions, identification and traceability, prevention of product mix-up, in-process controls and final inspection activities.
• Own the design and process transfer, scale-up and manufacturing readiness activities, ensuring that production specifications, inspection methods, validation evidence, risk controls, training requirements and manufacturing documentation are adequately established before routine production.
• Lead Quality Engineering oversight of manufacturing and inspection records, with a focus on traceability, data integrity, documentation robustness and DHR readiness. Identify recurring documentation issues or systemic weaknesses and drive improvements to manufacturing records, inspection records and production documentation processes.
• Define Quality review of production changes, assessing potential impacts to validated state, product conformity, risk controls, traceability, regulatory commitments and manufacturing readiness.
• Partner closely with Manufacturing, Microfabrication, Device Development and Supply Chain to ensure production processes remain controlled and capable throughout the product lifecycle.

Validation, Equipment & Measurement Systems

• Lead independent Quality oversight of process, equipment and test method validation activities within assigned manufacturing areas.
• Define and govern validation strategies, risk-based acceptance criteria, protocols, deviations and reports, ensuring that validation evidence is scientifically and statistically justified, traceable to applicable requirements and sufficient to demonstrate process capability and control.
• Drive Quality oversight of critical production and laboratory equipment, including qualification activities, calibration and maintenance compliance, requalification decisions and assessment of the impact of equipment changes or failures on product quality and process control.
• Ensure production inspection and measurement methods are suitable for their intended use, including verification, validation and measurement system assessments where applicable.
• Own the maintenance of validated processes and qualified equipment through periodic review, change assessment and risk-based decision making.

Nonconformity, CAPA & Change Control

• Lead complex nonconformity investigations related to production, equipment, facilities, cleanroom activities and manufacturing processes.
• Apply structured root-cause analysis methodologies, challenge unsupported conclusions and ensure corrective and preventive actions are evidence-based and proportionate to risk.
• Establish the effectiveness of implemented corrective actions and identify recurring or systemic issues requiring broader process improvements.
• Drive manufacturing change control activities and assess the quality impact of proposed process, equipment, material, supplier, facility and inspection method changes.
• Escalate significant quality issues, trends or validation gaps that may affect product safety, compliance, release readiness, manufacturing continuity or approved risk controls.

Cleanroom & Contamination Control Oversight

• Own Quality Engineering oversight of controlled environments and cleanroom activities within assigned manufacturing areas.
• Lead implementation and maintenance of contamination-control measures, including personnel practices, gowning, cleanliness controls, material and equipment entry controls, environmental monitoring and response to environmental excursions.
• Review environmental monitoring data, identify adverse trends and ensure appropriate investigations, risk assessments and corrective actions are performed when limits are exceeded.
• Drive compliant behaviours and contamination-control awareness through coaching, training support and continuous improvement initiatives.
• Support qualification and ongoing monitoring of facilities and controlled environments as required.

Supplier & CMO Production Quality

• Lead Quality Engineering oversight of production-related suppliers and contract manufacturing organizations (CMOs) whose activities may affect product quality, manufacturing robustness or supply continuity.
• Define supplier qualification, audit follow-up, quality performance monitoring, investigation activities, supplier change assessments and implementation of risk control plans.
• Analyze and drive supplier-related deviations, nonconformities and corrective actions, ensuring appropriate risk-based resolution when supplier performance impacts product quality.
• Drive alignment with Supply Chain and Supplier Quality functions to ensure supplier controls remain effective and aligned with applicable regulatory and quality requirements.
• Own external manufacturing transfers, manufacturing readiness assessments and quality oversight of outsourced production activities.

Quality Metrics, Continuous Improvement & Technical Leadership

• Lead the production quality performance metrics, including nonconformities, process trends, inspection results, environmental monitoring, validation status, equipment compliance and CAPA effectiveness.
• Translate quality data into actionable recommendations that improve process capability, quality performance, manufacturing readiness and operational effectiveness.
• Drive technical coaching and mentorship to Quality Engineers and production personnel on production quality, risk management, investigations, controlled manufacturing practices, documentation and quality systems.
• Lead or support cross-functional quality improvement initiatives aimed at reducing risk, strengthening controls and improving quality culture.
• Establish and maintain internal audits, external audits, notified body inspections and FDA readiness activities related to manufacturing operations, facilities, equipment, process controls and monitoring activities.
• Act as the primary Quality Engineering partner for assigned manufacturing areas, providing independent quality judgement while working collaboratively with operational stakeholders.