Senior Quality Engineer

Cardinal Health•Riverview, FL

11d

About The Position

What Quality Engineering contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Engineering is responsible for product and service quality planning, evaluation and control. Works cross-functionally in the development and implementation of prevention-based methodologies used in design, manufacture, test, sustainability and correction of products and services. Job Description The Sr. Quality Engineer 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. The position is required to perform data extraction and some analysis from Quality Management Systems to facilitate communication, management, and action, to measure performance against Key Performance Indicator, site, and departmental goals. The role will be required to engage in, assist, and follow through on internal and external audits by compliance, regulatory, and notified bodies. The position will have opportunity to participate in quality system process improvement initiatives.

Requirements

Bachelors in related fields (engineering, industrial engineering) or equivalent work experience, preferred
2-3 years of experience preferred

Nice To Haves

ASQ Certified Quality Technician or Certified Quality Auditor preferred.
Six Sigma Lean Certification preferred.

Responsibilities

Performing and documenting customer complaint root cause investigations.
Performing and documenting root cause investigations related to raw material, product and component rejections.
Writing protocols and performing validations of new/improved materials and processes.
Responsible for assisting QA Manager in designing, building, and managing the facility Quality System to achieve compliance with regulations.
Generating and maintaining Quality System documentation.
Ensures products manufactured or processed in the Tampa facility are safe and effective.
Ensuring FDA/ISO compliance in areas of responsibility.
Manage noncritical projects with input from QA Manager.
Presenting quality data to Management.
Supporting Production personnel by resolving process and material-related quality problems in support of the various manufacturing departments.
Supporting 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.
Performing regular internal audits of the Quality System.
Performing Quality Systems audits of suppliers.
Revising documents using the AGILE documentation system.
Lead and support change control via the AGILE Change Request System (CDP).