Director of Operations

Frey Consulting Group; Dudley (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Henke Sass Wolf of America, Inc. in Dudley, MA seeks a Director of Operations to lead all production and internal logistics, ensuring alignment with safety, quality, delivery, cost, and people metrics.

The role emphasizes Just-in-Time principles and a culture of execution and continuous improvement. The ideal candidate has 5+ years in regulated manufacturing, strong leadership, and capability to manage change.

Qualifications

• Minimum five years of progressive experience in production or operations management in regulated manufacturing or medical-device environments.
• Strong analytical, problem-solving, and communication skills.
• Proven ability to manage multiple priorities and lead through change.
• Working knowledge of FDA QSR and ISO 13485 standards.

Responsibilities

• Own and deliver measurable improvements in throughput, on-time delivery, turnaround time and cost.
• Establish and sustain a daily management system with KPI-driven accountability.
• Lead structured problem solving across functions and build team capability.
• Align capacity planning, staffing and scheduling with customer demand.
• Standardize and continuously improve processes for predictable performance.
• Drive flow-based/value-stream operations.

Skills

Analytical skills

Problem-solving

Communication skills

Change management

Education

Operations Management / Business / Engineering degree or equivalent

Job description

Reports To: Chief Executive Officer (HSWoA CEO)

Location: Dudley, MA

FLSA Status: Exempt

Compensation Range: $150,000 – $210,000 annual base salary

Incentive Compensation: Eligible for variable income bonus based on company and individual performance

Position Summary

The Director of Operations provides strategic and hands-on leadership for all Production and internal logistics functions at Henke Sass Wolf of America (HSWoA). The role is accountable for operational performance across Safety, Quality, Delivery, Cost, and People.

As a member of the site leadership team, the Director of Operations drives sustainable performance through implementation of Just-in-Time principles (Takt, Flow, Pull, Zero Defects) and develops a high-accountability culture focused on execution and continuous improvement.

Operational Performance & Execution

• Own and deliver measurable improvements in throughput, on-time-delivery, turnaround-time and cost.
• Establish and sustain a daily management system with meaningful KPIs and accountability to implement countermeasures to stay on track.
• Lead structured problem-solving across functions; develop capability within the team.
• Align capacity planning, staffing and scheduling with customer demand.
• Standardize and continuously improve processes to ensure predictable performance.
• Drive implementation of flow-based/value-stream operations.

Regulatory and Quality Compliance

• Ensure operations comply with FDA QSR (21 CFR Part 820) and ISO 13485.
• Maintain training discipline, documentation accuracy, and audit readiness.
• Support the Quality Management Team during audits, inspections, and management reviews as the Operations representative.

Leadership and Culture

• Lead, coach and develop Production Managers and Team Leaders.
• Foster ownership, urgency, transparency and cross-functional collaboration.
• Translate company strategy into clear operational priorities.
• Build a culture of accountability and continuous improvement.
• Develop leadership capability within the operations organization by mentoring managers and building succession strength for critical roles.

Key Performance Indicators

• Repair throughput (units/day)
• On-Time Delivery (OTD) and Turnaround Time (TAT)
• Direct labor productivity and material usage variance
• Warranty return rate
• Inventory accuracy and material availability
• Audit readiness and training compliance
• Employee engagement and leadership development

Qualifications

• Operations Management, Business, Engineering, or a related field, or equivalent progressive leadership experience in manufacturing or regulated production operations. Minimum five years of progressive experience in production or operations management within a regulated manufacturing or medical-device environment.
• Demonstrated success leading change.
• Strong analytical, problem-solving, and communication skills.
• Proven ability to manage multiple priorities and lead through change.
• Working knowledge of FDA QSR and ISO 13485 standards.

On-site leadership presence is required in a regulated medical-device production and service environment. Occasional travel to corporate headquarters or supplier sites may be required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Training Requirements

• Job training according to the current Training Plan.
• Ongoing training for continual improvement.
• General Safety, GMP, and OSHA training as required.

EEO and Equal Pay Statement

Henke Sass Wolf of America, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by law.

We comply with all applicable pay-transparency, fair-employment, and equal-pay laws, including the Massachusetts Equal Pay Act and the Massachusetts Pay Transparency Law. Compensation decisions are based on job-related factors such as skills, experience, and internal equity. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

This job description is intended to describe the general nature and level of work performed. It is not intended to be an exhaustive list of all duties, responsibilities, or qualifications. Management reserves the right to modify responsibilities as business needs evolve.