Director of Operations

True Function; La Mesa (CA); On-site; USD 80,000 - 85,000; Full time

Job summary

True Function Laboratory, Inc seeks a Director of Operations to lead day-to-day performance, translate priorities into disciplined execution, and ensure the organization has people, processes, and systems to deliver quality products efficiently.

The role includes managing Production and Quality teams, owning operational KPIs, developing scalable SOPs, budgeting, and coordinating with cross-functional leaders. A strong background in regulated industries and QMS is highly valued.

Qualifications

• Bachelor’s degree in a related field or equivalent experience.
• Progressive leadership experience in operations/manufacturing.
• Experience in a regulated industry preferred (medical/dental/biotech).
• Knowledge of FDA/QMS ISO 13485 and ability to serve as Management Representative.
• Budgeting, capacity planning, process improvements, and KPI tracking.

Responsibilities

• Direct Production and Quality teams and coordinate with governance/consultants.
• Translate goals into operational plans and own KPI performance.
• Develop managers, reviews, development opportunities, and compensation recommendations per policy.
• Develop scalable SOPs, training, cross-training, and EOS-style accountability with scorecards.
• Manage Operations budget and resources; seek productivity and cost improvements without sacrificing quality.
• Oversee vendor/supplier performance and risk management.
• Lead projects and product-launch readiness within budgets and priorities.
• Collaborate with Sales, Customer Service, Finance, People/HR, R&D, and other leaders to support objectives.
• Serve as QMS Management Representative and report performance to top management.
• Ensure quality procedures, CAPAs, audits, regulatory compliance; escalate risks.
• Provide concise operational reporting to CEO and leadership with priorities and deviations.

Skills

Leadership

Budgeting

Capacity planning

Process improvement

Project management

Vendor management

Operational KPIs

Regulatory compliance

Education

Bachelor’s degree in Operations, Engineering, Business, Manufacturing, or related field

Job description

Compensation:

$80,000 - $85,000 Annually + Potential 10% Bonus on Annual Base Salary

Position Purpose

The Director of Operations leads and continuously improves True Function Laboratory’s day-to-day operational performance. The role translates company priorities into disciplined execution and ensures the organization has the people, processes, capacity, systems, and management infrastructure required to deliver quality products efficiently and reliably.

The Director builds a high-performing operation with clear accountability, measurable results, documented processes, cross-training, and reduced dependency on any one individual. The Director provides the CEO with timely visibility into operational performance, significant risks, resource needs, and material exceptions without requiring CEO involvement in routine day-to-day operations.

Core Responsibilities

• Directly manage the Production and Quality teams, including their leaders, performance, staffing, and coordination with the Quality/Regulatory consultant or representative.
• Translate company goals into operational plans and own performance against agreed operational KPIs, including productivity, efficiency, turnaround, rework/remake performance, quality-related operational results, cost, and other established measures.
• Build, develop, and hold accountable Production and Quality managers, supervisors, and leads; partner with People/HR on objective performance reviews, development opportunities, recognition, and compensation recommendations under company policy.
• Develop scalable systems through SOPs, training, cross-training, and documented processes; implement and sustain a structured accountability and execution system (such as EOS) with scorecards, priorities, and clear ownership.
• Manage the Operations budget and resources; identify opportunities to improve productivity, capacity, margin, and cost efficiency without compromising quality, safety, compliance, or customer commitments.
• Oversee operational vendor and supplier performance and identify supply-chain, equipment, staffing, and business-continuity risks.
• Lead or support significant operational projects and product-launch readiness within approved company governance, budgets, and priorities.
• Collaborate with Sales, Customer Service, Finance, People/HR, Product Development/R&D, Business Development, and other functional leaders to support company objectives while respecting functional ownership boundaries.
• Serve as True Function’s designated Quality Management System Management Representative, ensuring QMS performance is reported to top management and collaborating with the Quality/Regulatory consultant or representative.
• Ensure Operations implements applicable quality procedures, CAPAs, audit commitments, corrective actions, and regulatory requirements; promptly elevate significant quality, regulatory, operational, customer, or business risks.
• Provide concise and reliable operational reporting to the CEO and leadership team, including performance, issues, priorities, risks, resource needs, and material deviations from agreed plans.

Qualifications

• Bachelor’s degree in Operations, Engineering, Business, Manufacturing, or a related field preferred; equivalent relevant experience may be considered.
• Significant progressive leadership experience in operations, manufacturing, or a related environment, including responsibility for managers or supervisors.
• Experience in a regulated industry strongly preferred; medical device, dental, healthcare manufacturing, biotechnology, pharmaceutical, or similar experience is particularly relevant.
• Working knowledge of FDA-regulated quality management systems and ISO 13485, with the capability and willingness to serve as the company’s designated Management Representative.
• Demonstrated experience with budgeting, capacity planning, process improvement, project management, vendor management, and operational KPIs.

Competencies & Success Factors

• Strong ownership, accountability, and follow-through.
• Disciplined execution and data-driven problem solving.
• Ability to build strong managers and teams without creating dependency on the leader.
• Clear, direct, respectful, and transparent communication.
• Sound judgment regarding priorities, decision authority, escalation, and cross-functional boundaries.
• Commitment to structured accountability, continuous improvement, documentation, efficiency, quality, and institutional knowledge.
• Ability to balance employee development with measurable performance expectations.

Physical Demands & Requirements

The physical demands and working conditions described below are representative of those required to perform the essential functions of the position. Reasonable accommodations may be made.

• Remain in a stationary position for extended periods and operate a computer and standard office equipment.
• Regularly move throughout office, laboratory, and production areas.
• Occasionally lift or move materials up to 20 pounds.
• Communicate effectively through speech and written communication.
• Enter production areas requiring appropriate PPE and adherence to applicable safety procedures.