Sr. Engineer, Quality Operations

Sr. Engineer, Quality Operations

Responsible for compliance, validation, investigations and corrective action projects on designated Quality process/area responsibilities. Lead assessments for regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Leads and conducts root cause investigations for multi-group projects in the development of continuous improvement and corrective / preventative action philosophies and strategies. Meets required timelines and effectiveness check metrics for all assigned projects and NCR/CAPA's.

What you’ll be doing:

Lead NCR's, CAPA's and projects related to integration, remediation, or other items within a designated timeline to meet metric requirements through effectiveness checks.

Lead value stream monthly reviews of metrics and project status for the area. Decide on next steps and escalations for further review to improve the system, process or procedures.

Train and onboard team members to Quality team for operations. Facilitate and coach assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner. Provide mentoring, development and recommendations.

Organize, review, and update applicable Quality System Documentation. Support the data integrity initiatives to relevant systems, processes, and equipment.

Evaluate all relevant operational data, reports, statistics, and documentation related to assigned investigation processes and projects for product performance and product quality, to generate proactive and timely actions when needed to address a quality issue or improve a process.

Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes. Drives quality and manufacturing improvements to ensure our processes are in state of control.

Perform root cause investigation analysis and prepare reports, for negative trends of process or product failures or critical characteristics. Document such actions within the quality system as appropriate (NCR/CAPA). Apply standard operating practices and problem-solving methodology.

Assist in complaint/field return investigations related to manufactured product. Lead product projects monthly for responsible areas. Analyze returned components, recommend corrective actions, and follow-up on cross-functional team responses and implementation of corrective actions.

Lead process improvement projects (scrap reduction, defect reduction, etc.) with little or no guidance.

Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation for responsible areas. Provide guidance to other Quality Engineers for their designated areas as required.

Ability to provide requirements for change control based on procedural requirements.

What you’ll bring:

Minimum of a BA or BS in Engineering having a minimum of 4+ years related experience or 2 years related experience w/ an advanced degree or demonstrated performance and increasing responsibility within Quality roles.

Six Sigma green belt or ASQ CQE certification highly desirable.

Prior experience interacting with the FDA and other regulatory agencies a must.

Ability to work effectively with multi-department and multi-site teams Ability to manage and organize complex technical problems Good written and oral communication skills, excellent attention to details.

Strong team leader with management skills and focus on results

Strong scientific analysis and troubleshooting skills

Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of bulk and finished products and current industry standards related to sterilization, cleaning and other validation processes

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

While performing the duties of this job, the employee:

Must be able to sit for long periods of time

Must have good hand to eye coordination and dexterity

Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time.

WORK ENVIRONMENT

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:

Wearing a static protective smock at all times while in the work area

Wearing a ground wrist strap and plugging that wrist strap into the working table.

Working in close proximity to other employees.

Working in an environment that is temperature and humidity controlled.

We understand compensation is an important factor as you consider the next step in your career. At Baxter,