Operations Lead / Production Manager
Location: Albany, GA
Employment Type: Full-Time
Start Date: ASAP
Position Overview
We are seeking an experienced Operations Lead/Production Manager to lead manufacturing operations in a highly regulated medical device production environment. You will drive operational excellence, ensure production targets are achieved safely and efficiently, and develop high-performing teams. This is a hands-on manufacturing leadership role requiring strong knowledge of regulated processes, continuous improvement, and cross-functional collaboration.
You will oversee production operations while partnering closely with Quality, Engineering, Supply Chain, Maintenance, Environmental Health and Safety (EH&S), and other support functions to ensure operational success, regulatory compliance, and continuous improvement.
Key Responsibilities
- Lead day-to-day manufacturing and production operations to meet safety, quality, delivery, and cost objectives.
- Develop production schedules and allocate labor, equipment, and resources to meet customer demand.
- Build, coach, mentor, and develop frontline supervisors and production leadership teams.
- Foster a culture of accountability, employee engagement, and continuous improvement.
- Collaborate with Quality, Engineering, Supply Chain, Maintenance, Finance, and Environmental Health and Safety (EH&S) to achieve production goals.
- Ensure compliance with the United States Food and Drug Administration (FDA), Current GoodManufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), International Organization for Standardization (ISO) standards, Medical Device Regulation (MDR), and other applicable regulatory requirements.
- Monitor production metrics and Key Performance Indicators (KPIs) to identify opportunities for productivity, efficiency, quality, and cost improvement.
- Participate in capital planning, budgeting, and forecasting activities.
- Lead root cause investigations and implement Corrective and Preventive Action (CAPA).
- Drive Lean Manufacturing, Six Sigma, and operational excellence initiatives.
- Support equipment upgrades, process improvements, and operational projects.
- Manage multiple priorities while meeting production commitments.
Required Qualifications
- Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related technical discipline.
- 10+ years of progressive manufacturing leadership experience within a regulated manufacturing environment.
- Demonstrated experience leading production teams of 50+ employees through frontline supervisors.
- Strong understanding of United States Food and Drug Administration (FDA) regulations, Current Good Manufacturing Practice (cGMP) requirements, International Organization for Standardization (ISO) standards, Medical Device Regulation (MDR) requirements, Occupational Safety and Health Administration (OSHA) regulations, and quality system requirements.
- Experience with production planning, labor scheduling, capacity planning, and operational budgeting.
- Proven leadership, coaching, and talent development skills.
- Excellent analytical, problem-solving, and decision-making abilities.
- Strong communication skills with the ability to influence across all levels of an organization.
Preferred Qualifications
- Medical device manufacturing experience.
- Experience implementing Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
- Experience with Medical Device Regulation (MDR) and TÜV SÜD regulatory requirements.
- Experience in similarly regulated industries (aerospace, food and beverage, pharmaceutical).
Compensation & Benefits
Salary: $125,000 to $145,000
Bonus: 17% target bonus
Benefits Package:
- 100% medical premium coverage for employees and dependents.
- Dental and vision plans.
- 401(k) with a 100% company match on the first 4% contribution.
- 7% safe harbor retirement contribution.
- Paid time off and company shutdown days.
- Tuition reimbursement.
- Financial wellness program access.
- Relocation support available.
About This Opportunity
This is an onsite position with an established medical device manufacturer. You'll work in a collaborative environment with experienced leadership and modern manufacturing facilities. The role reports directly to the Plant Manager and offers the opportunity to make a significant impact on production operations and team development.