What Quality Engineering contributes to Cardinal Health
Quality Engineering is responsible for product and service quality planning, evaluation and control. Also, is the responsible for the Process and Product Validations. Works cross-functionally in the development and implementation of prevention based methodologies used in design, manufacturer, test, sustainability and correction of products and services. Assure all products manufactured meets company policies and customer requirements. Manage and supervise the departments Quality Engineering and Validations. Evaluate the effectiveness of the process towards established requirements and develop a team approach for addressing any deficiencies in the Focus Factories (FF). Identify, evaluate and execute opportunities for continuous improvement consistently. Maintain documentation of department policies and procedures and ensure compliance with established certified standards, applicable regulations, and company policies. Work with management staff to ensure the department operates in a safe and cost-effective manner.
Facilitate QA activities relating to Quality Process Requirements in areas of assigned responsibility.
Collaborate in the development and analyze of data to readily identify problems and to provide trend analysis and improvement opportunities. Work in liaison with Supplier Quality to assure compliance and continuous improvement.
Manage department personnel, coordinate work assignments, maintain safe and secure working environment.
Responsible for nonconformance product dispositions.
Evaluate individual and team performance and coach and mentor direct reports.
Coordinate professional development and skills training of department personnel.
Assure regulatory compliance to meet the requirements of established certified standards, regulations and customer requirements.
Review protocols and final reports for validating new equipment and processes or revalidating current equipment and processes to assure capability and compliance in meeting quality expectations.
Responsible for product/process improvement/development efforts by working with Production, Engineering and other functions to identify, implement, and validate product/process changes.
Assure that investigations for NCR / CAPAs and Complaints related to the FF are performed adequately and in a timely manner.
Perform other duties as assigned, with or without accommodation.
Develops, modifies, applies and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Defines and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs and analyzes inspection and testing processes, mechanisms and equipment.Performs statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications.
May specialize in the areas of production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
May be certified in lean and six-sigma quality engineering methodologies.
Support investigations related to quality issues as complaints, in-process, NCRs, CAPAs and reviews the results of manufacturing investigations. Responsible for deviation investigations, out-of-specification results investigations, and atypical result investigations.
Bachelor’s Degree in Engineering or related field.
7+ years’ QA experience in a highly regulated manufacturing environment including 3+ yrs experience in medical device and/or pharmaceutical manufacturing environment
Advance proficiency in English/Spanish
Solid leadership skills and ability to guide and mentor others.
Acts as SME in Validation, manufacturing processes, equipment, products and raw materials. Ability to demonstrate knowledge in the area of software validation.
Working knowledge and auditing experience in US and international regulatory and quality assurance requirements (FDA 21 CFR Part 820, ISO 13485 and other regulations as applicable) associated with the development and manufacture of medical devices.
Working knowledge of inspection and test techniques, quality assurance procedures, statistical analysis, product usage and device regulations.
Working knowledge of medical device quality systems and applications.
Demonstrated ability to work successfully, leveraging interpersonal, communication, and technical skills to optimize results
Good analytical and statistical problem solving tools.
Solid Leadership skills, ability to mentor, coach and develop others including establishing succession planning programs
Working knowledge of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab.
Good verbal (including presentation) and written communication skills, especially technical report writing.
Strong organizational and project planning skills.
Skilled in quality plan development and basic statistical methods (Quality testing, SPC, sampling plans, process capability and graphical analysis).
Skilled in root cause analysis and failure investigation – Risk Assessment (desired)
ISO 13485 or 9001 Certified Lead Auditor (desired)
Quality Engineering Certification (desired)
What is expected of you and others at this level
Manages department operations and supervises professional employees and/or business support staff
Participates in the development of policies and procedures to achieve specific goals
Ensures employees operate within guidelines
Decisions have a short term impact on work processes, outcomes, and customers
Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management
Interactions normally involves resolution of issues related to operations and/or projects
Gains consensus from various parties involved
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. I have discussed the contents of the document with my supervisor and understand the expectations that have been set forth.
Responsibility for Safety:
Cardinal Health considers the safety of all employees to be of the highest priority. As such, it is the responsibility of each employee to treat safety in the same regard. Strict adherence to established plant safety policies and procedures is expected of each employee. Unsafe conduct and failure to abide by plant safety procedures will result in appropriate disciplinary action.
Responsibility for Quality:
Every employee has the responsibility to ensure that we maintain the highest quality standards for manufacturing medical products. Every employee is expected to understand and comply with all applicable regulations, and Cardinal Health’s Medical Devices Guide to Compliance and Quality Manufacturing. These standards and regulations define the basic requirements for the design and production of medical devices.