Director, Quality & Operational Excellence

ENSURGE•San Jose, CA

4d•$225,000 - $275,000•Onsite

About The Position

Ensurge is seeking a Head of Quality & Operational Excellence to build, lead, and own two tightly linked systems: the company’s end-to-end quality system — from incoming materials through customer delivery and field performance — and the operational excellence system that makes manufacturing stable, standardized, and continuously improving as it scales. This is a player–coach role. You will define and execute strategy while remaining close to the factory floor and the product. You will own the quality management system and the customer-facing quality relationship, and you will simultaneously own the continuous-improvement engine: daily management, standard work, lean flow, structured problem-solving, and the manufacturing-readiness discipline that governs how processes transfer from engineering into stable production. Reporting to the COO, this leader is central to Ensurge’s ability to earn and keep customer trust at scale — and to convert a developing manufacturing line into a repeatable, transferable, and improving production system.

Requirements

Proven experience leading both quality engineering and operational excellence / continuous improvement in a high-tech manufacturing environment — semiconductor, battery, thin film, medical devices, or equivalent precision manufacturing.
Deep hands-on expertise with QMS design and implementation, FMEA (DFMEA & PFMEA), SPC, control plans, and CAPA.
Demonstrated mastery of an operational excellence/production system: daily management, standard work, lean flow, value-stream mapping, and structured problem-solving (8D, A3, DMAIC, Kaizen).
Strong background in customer-facing quality: PPAP, product qualification, corrective action responses, and field quality management.
Experience owning change management and configuration control in a regulated or high-consequence manufacturing environment.
Track record of building quality and operational systems from early-stage or reactive states into mature, scalable programs — i.e., a builder of systems, not just an operator of mature ones.
Strong data orientation — comfortable with quality metrics, yield analysis, OEE, and using data to drive decisions.
Ability to operate as both a technical expert and an organizational leader.
Player–coach mentality — leads from the front and builds others up without creating bottlenecks.
Deeply accountable — treats product quality, customer trust, and operational stability as personal responsibilities.
Systems thinker who understands that quality and throughput are the output of process discipline, not inspection effort or firefighting.
Calm under pressure; decisive when excursions or production issues demand a fast, structured response.
Collaborative and low-ego — earns influence through rigor and results, not authority.
Comfortable operating in ambiguity — able to build structure where none exists.
Relentlessly improvement-oriented — never satisfied with ‘good enough’ when better is achievable.

Nice To Haves

Experience supporting pilot manufacturing or first-of-kind production lines through scale-up.
Familiarity with roll-to-roll processing, thin-film deposition, laser processing, or semiconductor-style fabs.
Background with ISO 9001, IATF 16949, or equivalent quality management standards.
Experience deploying a recognized production system (TPS-based or equivalent) across a scaling organization.
Experience with MES, LIMS, traceability systems, and data-driven quality/manufacturing infrastructure.
Certified Quality Engineer (CQE), Six Sigma Black Belt or Master Black Belt, or equivalent credentials.
BS / MS in Engineering, Materials Science, or equivalent field.

Responsibilities

Design, implement, and own Ensurge’s Quality Management System — structured for a scaling manufacturing organization.
Establish document control, change management, and record retention aligned with industry standards (ISO 9001, IATF 16949, or equivalent).
Build audit-readiness into daily operations — a continuous state, not a periodic event.
Drive a quality culture where data is visible, decisions are traceable, and accountability is clear.
Own product quality from design release through customer acceptance — including outgoing inspection, CoC, and quality records.
Lead customer quality engagements: requirements reviews, PPAP / product qualification, corrective action responses, and field quality feedback.
Develop and manage customer-specific quality plans, control plans, and acceptance criteria.
Establish and track product reliability and field performance metrics; drive closure on customer escapes or warranty issues.
Serve as the primary quality interface with customers, ensuring trust and transparency.
Implement Statistical Process Control (SPC) and process monitoring across critical manufacturing steps.
Own the development and maintenance of control plans, FMEAs, and process qualification documentation.
Partner with Manufacturing Engineering to embed quality gates, sampling plans, and in-process checks into production flows.
Drive first-pass-yield improvement through structured problem-solving — not heroics.
Ensure clear out-of-control action plans (OCAPs) exist and are followed at every critical parameter.
Lead Design FMEA (DFMEA) and Process FMEA (PFMEA) development across product and manufacturing programs.
Ensure FMEA outputs drive real risk mitigation — linked to control plans, SOPs, and inspection criteria.
Maintain living FMEA documents that evolve with the product and process.
Facilitate cross-functional FMEA reviews with R&D, Manufacturing, and Equipment teams.
Own the end-to-end excursion process: containment, root cause analysis, corrective action, and effectiveness verification.
Establish escalation protocols and response SLAs for quality escapes, yield excursions, and customer complaints.
Lead structured 8D / CAPA processes — driving to root cause, not symptom treatment.
Ensure lessons learned feed back into FMEAs, control plans, and design standards — so no excursion repeats for the same root cause.
Own the ECO / Change Control Board (CCB) process — ensuring process, material, and design changes are reviewed, validated, and documented before implementation.
Define change classification frameworks: what requires full requalification vs. validated equivalence.
Ensure changes are fully traceable from initiation through implementation and verification.
Partner with R&D and Manufacturing to balance innovation velocity with quality rigor — fast learning without uncontrolled risk.
Maintain product and process version control linked to manufacturing travelers and quality records.
Establish supplier quality management: qualification, audit, scorecard, SCAR, and incoming inspection standards.
Build in-process inspection and sampling strategies aligned to process capability and risk.
Define outgoing quality gates, acceptance criteria, and release processes for all shipped products.
Ensure traceability from raw material through finished good — enabling rapid containment and lot genealogy.
Own the measurement system and gauge management program: MSA, calibration, and capability validation.
Partner with Equipment Engineering to qualify and maintain inspection and test equipment.
Ensure measurement uncertainty is understood and controlled at every critical quality checkpoint.
Build and own Ensurge’s operational excellence framework — the management system that turns isolated improvements into a sustained, company-wide capability.
Define the improvement roadmap and prioritization model so effort is spent on the constraints that most affect yield, cost, throughput, and delivery.
Establish operational KPIs and a single source of truth for performance, in partnership with Data & Automation.
Make improvement a line responsibility — coaching leaders and teams rather than running a separate ‘improvement department’ in isolation.
Stand up a tiered daily management system — tier boards, daily huddles, and escalation paths that surface problems within hours, not weeks.
Define the metric hierarchy (safety, quality, delivery, cost, people) and the cadence that connects the floor to leadership reviews.
Build a visual factory: real-time status, andon/escalation triggers, and clear ownership at every level.
Use DMS data to drive disciplined daily decisions and to feed structured problem-solving — not just to report status.
Own the manufacturing-readiness gate: no process is released to Operations until the process spec, SOP, control plan, and verified technician training are complete — verified, not assumed.
Govern the clear separation between Engineering (creates and improves processes) and Operations (runs the released process), preventing the ‘engineering trap’ in which engineers are permanently tied to the floor.
Establish standard work, the Process of Record (POR), and change-control discipline to ensure processes remain stable, transferable, and auditable.
Apply the readiness test — ‘can a trained technician run this process without the engineer?’ — as the objective criterion for process closure.
Partner with Manufacturing Engineering and Technology so lessons from pilot tools feed cleanly into next-generation designs.
Drive waste elimination and flow improvement across Assembly, Laser, and Material Handling — reducing WIP, cycle time, and non-value-added steps.
Lead value-stream mapping and line-balancing to expand effective capacity ahead of demand.
Own OEE improvement in partnership with Equipment & Facilities (availability, performance, quality).
Translate operational gains into measurable cost and unit-economics improvement as the line scales from pilot to volume.
Deploy 5S / workplace organization as a foundation for stability, safety, and visual control.
Standardize the problem-solving toolkit — 8D, A3, DMAIC, and Kaizen — and make it the default response to recurring loss.
Lead and coach Kaizen and rapid-improvement events that deliver verified, sustained results — not one-time gains.
Build problem-solving capability across the organization through training, certification, and hands-on coaching at the gemba.
Establish a closed-loop learning system so root causes are captured once and designed out everywhere.
Build and lead a high-performing team spanning quality engineering, inspection, quality systems, and continuous improvement.
Establish clear roles, performance expectations, and development paths — leading as a player–coach without creating bottlenecks.
Serve as a key thought partner to the COO on quality risk, customer readiness, operational maturity, and scaling strategy.
Embed a culture where teams own the product and the system — not just their individual step.