Sr. Engineer, Quality Operations

Baxter • Skaneateles Falls, NY

2d • $96,000 - $115,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter: 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. Your Team at Baxter: Within Quality Ops, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products. We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers. 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.

Requirements

• 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.
• Prior experience interacting with the FDA and other regulatory agencies a must.
• Ability to work effectively with multi-department and multi-site teamsAbility 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
• Must be able to sit for long periods of time
• Must have good hand to eye coordination and dexterity
• Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time.

Nice To Haves

• Six Sigma green belt or ASQ CQE certification highly desirable.

Responsibilities

• 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.

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees