Sr. Quality Engineer - Validation and Regulatory Compliance in Medical Devices - Baxter - Marion, NC

Join the Baxter Team as a Senior Quality Engineer and Make a Difference in the Lives of Patients Worldwide

At Baxter, we're driven by a mission to save and sustain lives. For over 85 years, we've been at the forefront of medical innovation, transforming healthcare and improving outcomes for millions of patients globally. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home. We're now seeking a highly skilled and experienced Senior Quality Engineer to join our team in Marion, NC. As a Sr. Quality Engineer, you will play a critical role in ensuring the quality and compliance of our medical devices, working closely with cross-functional teams to drive success.

About the Role

We're looking for a seasoned Senior Quality Engineer with a strong background in validation and regulatory compliance. As a Sr. Quality Engineer at Baxter, you will be responsible for providing hands-on validation support to several facilities, utility, and equipment qualifications. You will work closely with our Manufacturing, QC, Engineering, and Quality Management departments to develop and implement new processes and technologies. Your expertise will ensure that our systems and applications meet regulatory quality standards, and you will play a key role in driving continuous improvement and innovation.

Key Responsibilities:

• Provide hands-on validation support to several facilities, utility, and equipment qualifications, including Automated Visual Inspection Systems, Automation Systems Validation, Analytical Laboratory Systems Validation, Computer Systems Validation, Formulation Equipment Qualification, Filling and Packaging Equipment, Clean Room Qualifications, and Water for Injection systems.
• Ensure FDA regulations are met for system upgrades/replacements, including the 2011 FDA Guidance for Process Validation and USP Chapter <1790> Visual Inspection of Parenterals.
• Perform process validation, process capability, and process control studies for assigned projects.
• Support the development and implementation of new processes and technologies, working closely with cross-functional teams.
• Participate in medium to large-size projects, own work, and produce detailed requirements and analysis documents.
• Partner with other support groups and manufacturing teams to complete work.
• Develop test requirements and prepare and document test data for complex system testing.
• Provide support to resolve technical issues with systems under validation.
• Ensure computer systems and applications follow regulatory quality standards through validation activities.
• Communicate optimally in written and verbal form.

Requirements and Qualifications

Essential Qualifications:

• Bachelor's degree in Engineering (ME, IE, CHE, BME, EE, CE) with a minimum of 3 years of validation experience.
• Experience in the pharmaceutical/biotech industry, specifically in Quality Assurance and/or Validation.
• Knowledge of applications such as MS Office: Word, Excel, PowerPoint, Outlook, Microsoft Project, and other business applications.
• Understanding of software systems and how to appropriately test.
• Ability to work with a diversified multi-functional team across different plant locations.
• Self-motivated and works well without direct supervision.
• Ability to quickly learn and understand applications.

Preferred Qualifications:

• Experience with Wonderware, Allen-Bradley PLC.
• Knowledge of IQ/OQ/PQ and Data Integrity (ALCOA).

What We Offer

At Baxter, we're committed to providing a comprehensive benefits package and a competitive salary. This position has a salary range of $60,000 to $132,000 per year, with an annual incentive bonus. Our benefits include:

• Medical, Dental, and Vision coverage.
• 160 hours of Paid Time Off and Paid Holidays.
• 401K match.
• Employee Stock Purchase Program.
• Paid Parental Leave.
• Tuition Reimbursement.

Work Environment and Culture

At Baxter, we're dedicated to creating a work environment that's inclusive, diverse, and supportive. We believe in fostering a culture of innovation, collaboration, and continuous learning. Our Marion, NC site is a large manufacturing facility that requires a dynamic and flexible work environment. As a Sr. Quality Engineer, you will be expected to work collaboratively with cross-functional teams, and you may be required to work days, nights, holidays, and/or weekends as needed by the project timeline.

Physical Requirements

This role requires:

• Continuous grasping, pushing/pulling up to 20 pounds and reaching with hands and arms.
• Lifting and carrying on average up to 20 pounds frequently throughout the shift.
• Normal visual acuity and the ability to distinguish color.
• The ability to complete quick and detailed repetitive processes using both arms and both hands.
• Occasionally specialized physicals are required when working with certain drug codes.
• The ability to squat, climb, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist, and balance.

How to Apply

If you're a motivated and experienced Senior Quality Engineer looking to make a difference in the lives of patients worldwide, we encourage you to apply for this exciting opportunity. Please submit your application today, and join our team at Baxter.

We are an equal opportunity employer and welcome applications from diverse candidates. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.