PSP Senior Business Manager

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.

Principal Duties and Responsibilities:

• 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.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• 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.

Education/Experience Requirements

• 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.

Travel Requirements

Up to 10%

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ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws.

ZimVie generally does not sponsor applicant work visas for this position.

• Requisition ID: 2883