Supervises employees responsible for Quality Inspection.
**Key Responsibilities**:
- Supervise employees and quality activities pertaining to the production of products and/or manufacturing processes in - and with quality/technical knowledge of 2 or more production areas, depending on the complexity of the areas, in addition to conducting performance reviews, including resolving performance issues
- Develop and maintain sampling methods and procedures for inspections, testing and evaluation. It supports Quality Operations to guarantee that the products and processes comply with the relevant requirements of the Quality Management System
- Support activities related to the evaluation of product risks for non-compliant distributed products.
- Develop and support ongoing improvement activities to improve Quality Systems, using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, SPC, Kaizen Lean methods, DOE, etc.
- Partner with engineering on investigations and/or corrective actions, perform non-conformance investigations for review with engineering, assures documentation content is valid, may participate in improvement projects
- Oversee the scheduling of work orders and team performance metrics
- Ensure appropriate staffing for all positions
- Other incidental duties
**Education and Experience**:
Bachelor's Degree in in Industrial Engineering, Business Administration or related field required, 2 years years experience with internship, or substantial technical knowledge and experience in assigned work area, and sufficient experience in related manufacturing, quality, medical device, pharmaceutical industry and/or product development engineering, with skill levels exceeding previous experience the requirements of the Supervisor I Required and
previous related experience with full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations in manufacturing, quality and/or product development engineering Required
**Additional Skills**:
- Proven expertise in Microsoft Office Suite with working knowledge of Enterprise Resource Planning (ERP) system, preferably JDE
- Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives
- Full understanding of quality procedures
- Ability to supervise/lead employees in a manufacturing environment with limited supervision
- Solid problem-solving, organizational, analytical and critical thinking skills
- Robust understanding of processes and equipment used in assigned work
- Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
- Ability to lead teams, provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- Knowledge of Lean Manufacturing concepts and Six Sigma
- Participate on cross-functional teams Engineering, management, Regulatory, Manufacturing, HR, Planning for the development of cohesive production operations
- May represent the organization to outside contacts, e.g., vendors, suppliers, contractors, staffing agencies
- Good written and verbal English communication skills
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
- Travel (day and overnight by car, air, train, etc.) will vary. Percentage of time is determined by Management
