Sterilization Operations Manager

Overview:

He/she drives achievement of improvement goals in Safety, Quality, Cost, Delivery, People Development, and Innovation.

Responsibilities:

• The Sterilization Operations Manager works closely with the Radiation Safety Officer (RSO) to implement and sustain a strong radiation surveillance and dosimetry monitoring program. He/she has overall responsibility to ensure that all radiation safety controls, systems and interlocks always protect Contec personnel.
• Ensures safety, health, environmental and radiation protection are given priority within sterilization operations. Works alongside the Safety Manager and the RSO to achieve continuous improvement in these areas.
• Establishes clear accountability for housekeeping in work centers and all public spaces within the operation. The housekeeping standard is for the entire facility to be maintained “Showplace Clean” every day using 5S and BEC methods.
• Maintains compliance with Contec Environmental, Health, & Safety policies and government regulations within sterilization operations.

• Sets the expectation that product is made right the first time by ensuring sterilization process controls and dosimetry systems are followed and continually improved.
• Works closely with Quality Department to maintain ISO9001 certification and adherence to ISO 11137-1, 2 and 3, as well as ISO/ASTM 51261.
• Works with Quality Engineering to identify root cause(s) for customer complaints and to implement corrective and preventive actions.

• Drives continuous improvement in cost, quality and delivery using lean manufacturing methods to identify and eliminate the seven (7) forms of waste.
• Responsible for the preparation of budgets and manage work centers in order to keep spending within budget.
• Ensures labor cost standards accurately reflect actual cost for manufactured products.
• Minimizes material variance and scrap. Identify and address root causes driving these.
• Responsible for analyzing departmental performance: Analyze trends of key metrics, identify and address root-causes. Lead the team implementing the corrective actions.

• Works closely with Supply Chain Planning to assure customer order demand is met within target lead times and on-time performance.
• Drives improvement in sterilization equipment uptime. Ensures clear accountability and follow-through exists for equipment cleaning and other preventive maintenance activities assigned to sterilization associates. Works closely with the Maintenance Manager for maintenance and PM activities performed by work center techs and Maintenance techs.

• Leads his/her direct reports: Sterilization Supervisors, Accelerator Engineer, Quality Engineer, and Dosimetry Technicians.
• Establishes clear metrics and maintains accountability for performance.
• Leads by example: Ensures that associates are always treated with dignity and respect.
• Recognizes that our people are our biggest asset. Nothing is accomplished without them.
• Develops individual leaders within the organization and builds Performance Teams capable of continually improving their own production center.
• Ensures all personnel is properly trained and given necessary tools to perform their assigned responsibilities. Training is documented per ISO9001 standards.
• Ensures related SOP’s and Work Instructions are followed.
• Provides regular and appropriate recognition and reward to associates who exemplify the Contec Core Values.
• Responsible for maintaining a sense of teamwork and fun in the workplace.
• Works closely with Human Resources to ensure we have adequate staffing to meet operations targets.

• Works closely with the R&D to drive rapid and reliable new product development (NPD) through timely completion of test runs.
• Assigns resources to multi-functional NPD teams and serves as gatekeeper for formal acceptance of new products by operations.

Others may be assigned.

Competencies:

Drives Engagement: Creating a climate where people are motivated to do their best to help

with organization achieve its objectives.

Communicates Effectively: Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Develops Talent: Developing people to meet both their career goals and the organization's goals.

Supports Core Values – Able to demonstrate support and adherence to Contec’s core values: respect for others, doing “whatever it takes” within Contec’s core values, vision, and strategic direction, exhibiting integrity, having a tolerance for risk, understanding there is life outside of work, enjoying the ride.

Requirements:

Bachelor of Science in Engineering, Industrial Management, or Business Management; 15+ years in a radiation sterilization leadership position with at least five (5) years as plant manager; or an equivalent combination of education and experience.

• Subject Matter Expert on Sterilization Operations Management: theory and applications. Significant experience in sterilization operations management, including green field startups.
• Possesses a continuous improvement mindset and has the practical experience in all applicable standards: ISO 11137-1, 2 and 3, as well as ISO/ASTM 5126.
• Strong project management experience: Has previously managed large construction projects, including oversight of construction company and all equipment vendors. Has documented history of holding vendors and suppliers accountable to ensure that the project is completed on time and under budget.
• Understands state permit requirements for large construction projects.
• Has previous E-Beam sterilization experience. X-Ray Radiation preferred.
• IBA’s Rhodotron experience a plus.
• Has a strong working knowledge of radiation dosimetry programs, including direct management of dosimetry personnel.
• Proven track record of successfully implementing lean manufacturing tools, such as:
• Visual controls, standard work, single piece flow, visual.
• Strategy deployment and value stream mapping
• Kaizen events on standard work, cell design, process and product, error proofing, and Kanban management.
• Experience managing manufacturing direct labor, warehouse personnel and sterilization technicians, including quality, maintenance, and engineering.
• Experience working within ISO environments.
• Experience working within large-scale ERP/MRP systems and proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
• GMP regulatory compliance / regulated industry experience a plus.

The work environment characteristics described here are representative of those that an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the associate is occasionally exposed to moving mechanical parts, fumes or airborne particles, and risk of electrical shock.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

In performing their duties, the associate must be able to detect, distinguish, determine, perceive, identify, recognize, and observe product characteristics and work activities.

Benefits:

• Competitive market salary with annual incentive
• PTO starting at 17 days
• 9 company observed holidays plus 1 floating holiday
• Community service PTO (up to 40 hours annually)
• Insurance benefits, including medical (PPO), dental, vision, short and long-term disability, life insurance
• Two types of Flexible Spending Accounts, 1) Medical Spending Account and 2) Dependent Care Spending Account
• 401k and a company match (100% up to 3%, and then 50% of the next 2% deferred)
• Tuition Reimbursement Opportunities
• Family Benefits
• Adoption Assistance Program, Infertility Treatment Coverage
• Maternity and Parental Leave
• Onsite Amenities
• Onsite gyms, onsite health clinic, canteen for refreshment
• Hybrid Work Options (based on department operations)