Demo

Director of Operations

Architect
Saco, ME Full Time
POSTED ON 4/21/2025
AVAILABLE BEFORE 6/21/2025

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Responsibilities to include overseeing safety, quality, manufacturing and production, scheduling, reporting, engineering, maintenance, and personnel management to successfully produce high quality products on time and within budget in an efficient and safe work environment
  • Ensure effective transfer of products and processes from R&D, including performance and process validation, and QC testing of manufacturing and production processes in a clean room environment for all MMQCI products, according to cGMP, 21CFR Part 820 and ISO 13485
  • Responsible for oversight of timely, effective troubleshooting, problem-solving, and root cause analysis, working with cross-functional teams to consistently provide high quality products to clinical laboratories.
  • Oversee continuous process improvement of Manufacturing, QC, Production, and business processes, proposing well-thought-out improvements, manual and automated, process engineering, and risk-based decision making
  • Work closely with Quality Assurance/ Regulatory Affairs Manager to ensure products and processes comply with 21CFR Part 820 and ISO 13485.
  • Ensure all manufacturing SOPs, safety, policies, and processes are adhered to by MMQCI staff according to cGMP, OSHA, and MMQCI’s Quality System

Job Type: Full-time

Pay: $78,819.33 - $94,922.20 per year

Schedule:

  • Monday to Friday

Experience:

  • Director of Operations: 5 years (Preferred)
  • Medical Equipment Manufacturing: 5 years (Preferred)

Work Location: In person

Salary : $78,819 - $94,922

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