What are the responsibilities and job description for the Director of Operations position at MMQCI?
EMPLOYER: Maine Molecular Quality Controls, Inc. (MMQCI), located in Saco, Maine, designs, develops, manufactures, and sells unique quality control products used by hospital laboratories and manufacturers to monitor the accuracy of tests for genetic, oncologic, and infectious diseases. We are a small, growing company, with patented technologies and offer a relaxed but challenging work environment.
POSITION TITLE: Director of Operations
GENERAL SUMMARY:
The Director of Operations reports directly to the President and will lead the operations of the business to ensure on-time delivery of high-performing products. The successful candidate will be an experienced leader with a strong engineering and manufacturing background, who is driven to motivate teams to achieve high standards of competence and performance to achieve company goals. They enjoy diving in to perform a variety of tasks at a fast pace, including problem-solving and implementation of news ideas, working closely with MMQCI managers. They are an innovative leader, skilled at bringing industry best practices to an organization to scale technology and position an organization for growth.
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.
- Oversee inventory control.
- Oversee capital projects and cost control.
- Pursue special projects as required by the President
- Assist President on all their duties if required.
- Bachelor’s, Master’s or Doctorate Degree in engineering or equivalent, preferably chemical engineering.
- Minimum of 7-10 years of relevant manufacturing experience, IVD preferred.
- Minimum of 7-10 years of engineering experience.
- Minimum of 5 years of management experience with at least 5 direct reports.
- Highly organized with proven leadership, management, and prioritization skills in a fast-paced environment.
- Expert knowledge of commonly used concepts, practices, and procedures within the engineering field.
- Strong problem-solving skills requiring technical data analysis while working with technical teams.
- Proven ability to handle pressure of meeting tight deadlines.
- Excellent written and verbal communication, with advanced computer skills, particularly Excel.
- Demonstrated Managerial Courage - takes action on poor performers, recognizes high achievers, and does not avoid difficult conversations.
- Familiarity with laboratory medicine, particularly molecular diagnostic assays used in hospital labs for patient care is preferred.
- Experience and/or interest in molecular biology techniques used in IVD manufacturing including cloning, sequencing, PCR, and electrophoresis is a plus.
- Knowledge of ISO and cGMP regulations is preferred.
- Must be a nonsmoker due to product contamination prevention requirements.
- Must be able to stand for several hours and lift approximately 30 lbs.
BENEFITS:
- Medical insurance
- Dental insurance
- 401(k)
- Profit sharing plan
- Vacation
- Holidays
- Sick leave
- Paid Parental leave
