Director of Ops - Regulated Med Device (On-Site)

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

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.