SUMMARY OF POSITION

　　Responsible for the control in-process testing and final inspection processes to assure product meets company policies and customer requirements. Evaluate the effectiveness of the process towards established requirements and develop a team approach for addressing any deficiencies. Identify, evaluate, and execute opportunities for continuous improvement consistently. Supervise a diverse team of employees, coordinate work assignments, evaluate department and individual performance and coordinate professional development of department employees.

　　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.

　　ESSENTIAL FUNCTIONS

　　Facilitate QA activities relating to Quality System Requirements in areas of assigned responsibility.

　　Assure product release is within quality requirements.

　　Develop and analyze data to readily identify problems and to provide trend analysis and improvement opportunities.

　　Work in liaison with Quality Engineering to assure compliance and continuous improvement.

　　Supervise QA Supervisors, maintain safe and secure working environment.

　　Work in the development of projects to improve QA Cost using statistical techniques and appropriate tools.

　　Responsible for managing and controlling nonconforming material in assigned areas and assuring their appropriate 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.

　　Develop and or 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. Assist in product/process improvement/development efforts by working with Engineering and other functions to identify, implement, and validate product/process changes.

　　Perform other duties as assigned, with or without accommodation.

　　Assure investigations and follow NCR / CAPAs and Complaints.

　　REQUIREMENTS

　　Education

　　Bachelor’s Degree in Engineering, Science, Management discipline or equivalent

　　Experience

　　Minimum five years’ experience minimum in a regulated Medical, pharmaceutical, Manufacturing environment.

　　Preferred: Four years Quality experience in medical device and/or pharmaceutical manufacturing environment.

　　Preferred Qualifications

　　Must be able to speak, read and write in the English language.

　　Two years prior leadership experience.

　　Certified Lead Auditor

　　Certified Six Sigma Green or Black Belt, CQE, CQA is a plus.

　　Requires excellent computer skills, proficiency in MS Office suite, Autocad and Minitab preferred.

　　Preferred Competencies

　　Good verbal and written communication skills, especially technical report writing.

　　Strong organizational and project planning skills.

　　Skilled in quality plan development and statistical methods (Hypothesis testing, SPC, sampling plans, DOE, Gage R&R, process capability and graphical analysis). Skilled in root cause analysis and failure investigation

　　Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

　　Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

　　To read and review this privacy notice click here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)

　　We are a team of nearly 48,000 mission-driven partners striving each day to advance healthcare and improve lives. We are Essential to care.

　　Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities

　　We are a crucial link between the clinical and operational sides of care, working with more than 4,500 sourcing and manufacturing partners to deliver end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

　　With 50 years of experience, approximately 44,000 employees and operations in more than 30 countries, Cardinal Health seizes the opportunity to address healthcare’s most complicated challenges — now, and in the future.

　　On Thursday, Jan. 7, 2021, we celebrated the day our founder, Bob Walter, had the vision to start a business that became known as Cardinal Health.

　　One of the most important ways we celebrated was by giving back to the communities where we live and work. 2021 was a "Year of Service” for all Cardinal Health employees around the world.

　　View Cardinal Health on YouTube (http://youtube.com/user/CardinalHealth)

　　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.