**_What Quality Control contributes to Cardinal Health_**
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Is responsible for overseeing a group of Quality technicians within a professional setting.
Their duties include relaying information between their team and upper management, guiding their team through daily work activities or projects and monitoring employee performance to ensure organization goals achievement.
Position is expected to function as a problem solver, capable of analyzing problems and implementing corrective/ preventive actions to mitigate/eliminate root cause determined.
Position maintains primary focus factory responsibility for critical quality systems including the internal audit program, CAPA system, and control of non-conforming product.
This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards.
Supports manufacturing Focus Factory activities by assisting in developing, implementing, and administering quality specifications, test methodologies, and sampling plans for product and process.
**ESSENTIAL FUNCTIONS**
- Responsible for seeing that all tasks are performed in a manner that complies focus factory
facility policies.
- Manage Quality Technicians team.
Provides constant feedback and communicating the company's and quality goals.
Setting goals for performance and deadlines to comply with company's plans and vision.
- Manage Nonconformance Program, including non-conforming material handling and process follow up.
Manage MRB area and recommend disposition of nonconforming product.
- Provide assistance and support to Quality department and others related to transfer, validation and qualification concepts, general process challenges and troubleshooting on the assigned manufacturing platform floor including event identification and quarantine processes, perform validation studies as required,
- Support Quality Assurance System, by developing subsequent corrective/preventive actions for internal audits, internal audits, as required.
- Documentation as required, including processing engineering change request.
- Metrics control and reporting.
- Knowledge of applicable regulatory standards.
- Determine root cause/corrective and/or preventive actions for CAPAs and NC.
- Assist in calibration activities and investigations.
- Participate in customer complaint investigations.
- Manage and/or participate on quality improvement projects including collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs.
- Support cost savings projects.
- Use of statistical tools to perform analysis and data trending, Uses various statistical and non-statistical problem-solving tools as part of analysis.
Support SPC program in assigned focus factory areas.
- Perform process risk assessment and failure mode effects analysis (PFMEA).
- Production Floor Support/Continuous Improvement Initiatives.
- Support resolution of production floor issues including aiding in problem solving.
- Maintain and evaluate sampling plans.
- Update/revise product control plans, inspection and test standards, and other site documentation where necessary.
- Provide career development, goals, training, and direction for Quality technicians.
- Comply with statutory responsibility under the national or federal regulations such as taking reasonable care of his or her own safety, health and welfare and of any other persons who may be affected by his or her acts or omissions at work.
- Follow established EHS procedures and policies.
- Encourage coworkers to follow EHS procedures.
- Participate in employee engagement activities such as EHS inspections and EHS meetings
- Report EHS incidents and hazards, assist in root cause analysis as appropriate, and cooperate in finding solutions or implementing improvement.
- Complete required EHS training.
**REQUIREMENTS**
- University studies initiated in Industrial, Chemical, Mechanical Eng.
or similar.
- ASQ CQE certification is desired or five year in medical device in position related to Supervision.
- 3+ years experience in medical device environment, preferably in Engineering or QA technician.
- English: Advance
**Preferred Qualifications**
- Quality System Standards, GMPs and Regulations experience is desired.
- Project Management, SPC, DOE, FMEA, CAPA, internal audits, process validations, root cause
- analysis, risk analysis techniques, capability studies knowledge is desired.
- Computer skills including statistical/data analysis.
- Dealing with ambiguity, creativity, timely decision making, quality decisions, functional/technical skills, innovation management, intellectual horsepower, learning on the fly, listening, managing and measuring work, organizing, perseverance, planning, priority setting, problem solving, process management, drive for results, managing through systems, techn