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GENERAL SUMMARY:   The Quality Engineering Manager is responsible for the outsourcing activities of the quality engineering department within the North America region.  This position is responsible for the planning, organizing, directing and carrying out of the quality engineering activities in order to meet the compliance and organizational goals.ESSENTIAL JOB FUNCTIONS:1. Develops policies and manages outsource supplier’s compliance program activities related to packaging, process, cleaning, equipment, method, sterilization, software, etc. for Smith & Nephew products.2. Directs and approves the quality responsibilities for product design and change control activities according to documented procedures.3. Implements the quality management system and ensuring functional compliance to the applicable FDA’s GMP’s, international standards and state requirements.4. Manages activities within the quality engineering area related to non-conforming material, CAPA, investigation, complaints, problem solving, trending, etc with outsourcing suppliers.5. Functions as a delegate to the Quality Assurance Manager for all qualifying activities in accordance with procedures.  This includes assignment of QA staff responsibilities and evaluation of performance for assigned responsibilities, and special project assignments.6. Determines and implements departmental goals and objectives by taking into consideration the Smith & Nephew strategic direction7. Issues periodic reports by developing plans for collecting, collective summarizing, and reporting required.8. Participates in Quality System activities such as:  GMP training for new and existing employees,  GMP awareness program,
60; Promotion of the quality system, Compliance to domestic and international regulations, Hosting/participating in external audits of the organization9. Approves and submit proposals considered feasible to management for consideration and allocation of funds from department budget.10. Manage the strategic direction and overall departmental success of quality employees, by providing leadership, planning and mentoring of personnel, scheduling priorities, reviewing work completion and applying direction, as necessary.11. Liaise with the ROW outsource quality individuals to identify consistent practices for outsource products and quality system elements.12. Demonstrate continuous improvement in both the application of technical solutions and the development of people, processes and systems. 13. Plans and executes supplier audits, CAPA review, and closure, etc.  Required SkillsPhysical:  Generally, this position requires 50 % sitting, and 50% standing/walking.  Requires the ability to move throughout the manufacturing facility on a daily basis.  Requires the ability to travel throughout the U.S., as well as internationally.  Manual Dexterity:  Requires high degree of continuous attention to detail while performing job requirements.  Requires ability to compose/revise specifications, Standard Operating Procedures, or any other applicable document(s) relating to our facility.  Requires a high degree of mental effort, and verbal skills required to effectively carry out the essential job functions outlined and to recognize potential problems throughout the facility as per Good Manufacturing Practices. Audible/Visual Demands:  Requires a high degree of ability to hear and comprehend instructions and react accordingly.  Requires ability to see in order to initiate, revise, evaluate protocols, SOPs, and specifications on a timely basis. Required ExperienceBS degree in an engineering field or science related field.Minimum of 8 years of Quality Engineering experience with a minimum of 3 years of management experience in medical device/drug Good Manufacturing practices environment.  Effective o

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