We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients' smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves - their best selves - to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future for ZimVie - we hope you'll consider being a part of it!

Job Summary:

Under general direction from the Director of Operations, directs and coordinates the commercialization and manufacture of company products to achieve customers' expectations and full satisfaction. The goals of accomplishing this include, but are not limited to, employee safety and development, product quality and compliance, budget administration, employee relationships and conformance to all related regulations applicable to medical device production. Partner with other members of management to define the strategy to achieve commercial and operational excellence in the launch and manufacture of products that are delivered on time and are cost competitive. Defines digital workflow solutions to grow the PSP business, automate solutions and provide customers with a streamlined process for case submissions. Utilizes Lean Manufacturing philosophy and best practices as the way of doing awhile driving continuous improvement and cost reduction victories.

• Manages assigned department to achieve quality, productivity, schedule, reliability, budget performance, safety, housekeeping standards and continuous process improvement.
• Provides leadership, training, counseling and guidance to subordinates. Confers with subordinates frequently to discuss performance and completes annual performance reviews.
• Interacts with production supervisors, QC, Planning, Scheduling, Engineering, Facilities, product and marketing managers and other personnel to achieve commercial and manufacturing goals.
• Ensures employee safety by promoting continuous appraisal of the manufacturing area and correction of potential problems. Participates in safety and housekeeping tours, correcting observations and preparing tour reports.
• Promotes good workmanship, product quality and zero-defect performance. Monitors rework and scrap, investigate causes of nonconforming product and determine necessary preventive action.
• Is knowledgeable of and complies with all federal and state laws and company policies.
• Analyze, identify, and prioritize opportunities for cost savings ultimately reducing standard cost/unit.
• Streamlining digital workflows operations and efficiencies while maintaining compliance and product and process integrity.
• Organize ownership/stakeholders of projects and establish accountability measures to ensure completion of projects.
• Establish OPEX metrics, tracks performance and drives metric attainment to ensure on time delivery and on time product launches.
• Report to management status and progress of OPEX projects. Elevate concerns of unsatisfactory resolutions or countermeasures.
• Coordinate and ensure proper resourcing of savings projects and establishing timelines for completion.
• Assure that the department meets and maintains FDA and ISO 13485 requirements, certifications and Plant Quality and Operational objectives.
• Performs related duties as required.

• Should have a broad business perspective, which includes the understanding of Customer Needs, Commercialization of Product, Quality Improvement Process, Manufacturing Processes, Validation Process, Budgets and Lean Manufacturing philosophies.
• Strong customer service and project management skills with the ability to coach, develop, and manage staff. Demonstrated strong interpersonal skills and the ability to manage conflict.
• Knowledge of FDA 820 Regulation (QSR's), GMP's, ISO regulations (e.g.: ISO 13485) and OSHA regulations and requirements.
• Requires professional written and verbal communication and interpersonal skills.

• Typically requires a B.S. / B.A. in Engineering, Business, Health Science, or equivalent combination of education and experience.
• Minimum of 8 to ten years' experience in a production/laboratory environment, preferably from a dental laboratory.
• Experience in FDA regulated environment, medical device preferred.

• Requisition ID: 2883