Job Number: 20019390
Location: Augusta, GA
Date Posted: 8-7-2017
Job Title: Sr. Quality Engineer
Sr. Quality Engineer
This position is primarily responsible for identifying opportunities for continuous improvement, formulating corrective and preventive actions, and working to implement those actions in order to improve quality levels and regulatory compliance. Supervisory responsibilities may entail the supervision of Quality Assurance Technicians. Responsible for assisting QA Manager in designing, building, and managing the facility Quality System to achieve compliance with the following regulations:
· ISO 13485, Quality Systems - Medical Devices - Quality Management Systems -Requirements for Regulatory Purposes
· FDA 21 CFR Part 820, Quality System Regulation (QSR)
· FDA 21 CFR Part 11, Electronic Records; Electronic Signatures
· FDA 21 CFR Part 803, Medical Device Reporting
· FDA 21 CFR Part 806, Medical Devices; Reports of Corrections and Removals
· FDA 21 CFR Part 810, Medical Device Recall Authority
· Council Directive 93/42 EEC of June 1993 concerning medical devices (Medical Device Directive), as amended by Directive 2007/47/EC
· Canadian Medical Devices Regulations, Health Canada SOR/98-282 (CMDR)
· Japan Pharmaceutical Affairs Law (JPAL)
· Australian Therapeutic Goods (Medical Devices) Regulation
· ISO 14971, Medical devices. Application of risk management to medical devices
· ISO 14969, Medical devices – Quality management systems – Guidance on the application of ISO 13485
Ensures products manufactured or processed in the Augusta facility are safe and effective. Expected to be able to manage critical projects with little or no direction from QA manager. The Senior QE serves as the Deputy Management Representative.
· Serves as the Deputy Management Representative.
· Performs and documents customer complaint root cause investigations.
· Performs and documents root cause investigations related to product and component rejections.
· Writes protocols and performs validations of new/improved materials and processes.
· Generating and maintaining Quality System documentation.
· Ensures regulatory compliance in areas of responsibility.
· Presents quality data to Management.
· Supports Production personnel by resolving process and material related quality problems in support of the various manufacturing departments.
· Supports plant cost reduction and process improvement projects through the use of various Quality tools such as FMEA, process capability, Gage R&R, pareto analysis, etc.
· Serves as primary backup with signature authority for the QA Manager.
· Responsible for allocating QA resources to ensure coverage for plant.
· In the absence of QA manager, has full decision making authority and should update/ contact Director of QA for critical quality decisions
· Serves as back-up contact for QA manager for corporate QA, R&D and regulatory affairs
· Performs regular internal audits of the Quality System.
· Performs Quality Systems audits of suppliers.
· Supports EH&S on Waste Management, Environmental, and DOT requirements.
· Supervises Chemistry and Raw Materials Labs.
· Environmental, Health and Safety (EHS) is a major cornerstone of this Company’s beliefs. Working safely and protecting the environment are an essential part of an employee’s job performance and all employees are responsible for adhering to plant EHS policies/procedures, report hazardous conditions or risks follow department EHS rules, PPE requirements, Good Manufacturing Practices (GMP’s), ISO 13485 regulations and Good Housekeeping procedures. All employees shall operate in a manner that protects the health and safety of its employees/visitors and operate in a manner that conserves energy, natural resources and protects the environment. In addition, all safety related incidents, no matter how slight, must be reported immediately.
Education required/ preferred:
4-year degree in a Scientific/Engineering discipline. Prefer BS in Chemistry or Chemical Engineering
Minimum of 5 years in a Quality Assurance environment.
Prior supervisory experience. Knowledge of ISO/EN/FDA, CMDR, JGMP and MDD Quality System requirements. Six Sigma experience required
Strong computer skills. Good organizational skills.
Physical Demands: The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions
Amount of Time
1/3 to 2/3 (Frequent)
4. Use Hand to Finger, Handle or Feel
5. Reach with Hands and Arms
6. Climb or Balance
7. Stoop, Kneel, Crouch or Crawl
8. Talk or Hear
9. Taste or Smell
10. Lift up to 10 lbs.
11. Lift up to 25 lbs.
Reports to Quality Assurance Manager .Directly supervises Chemistry and Raw Material technicians. Works closely with Focus Factory QEs and with Production Supervisors and department lead persons. Has frequent interaction with the Regional Engineering Manager and Engineers. Will occasionally interact with other department Managers and various plant salaried personnel. Frequently interacts with Mansfield Complaint Department, Scientific Services/Laboratory, R&D, and Packaging Development personnel.
The work environment is an office setting. Occasionally, and expected of this position, the duties require going on the manufacturing floor. The noise level in the manufacturing environment is relatively loud. Hair nets, beard covers and ear protection required while in manufacturing. Rings and exposed jewelry except for a close fitting watch are to be removed.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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