Quality Associate I (1st Shift)

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Your Role at Baxter

This is where your creativity addresses challenges

Responsible for quality assurance operation in the Devices/Molding Focus Factory. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Provide incoming, in-process and finished goods testing support. Involved in the development and revision of new standard procedures and training of employees. Assist department managers in audits or assessments and closures. Analyze and complete customer complaints. Perform department equipment and process validations. Serve as technical liaison among QM functional groups as well as other departments in the plant.

Your Team at Baxter

Cleveland’s technology and automation are groundbreaking. It is the U.S. sole source for plastic pour bottles, glass IV, and various reconstitution devices. This facility has a number of major product lines with a diverse array of automated manufacturing technologies ranging from bottle solution filling, injection molding, and device assembly.

Our Cleveland plant has been an integral part of Baxter for over 70 years. The work is challenging and rewarding, as Baxter offers competitive compensation and benefits. Baxter encourages and values every employee and believes that all can make a contribution to advancing healthcare for patients; work to be proud of.

What we offer from Day One

• 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

What you'll be doing:

• Review and release in-process and finished materials. Provide final approval, sign-off and release of in-process and finished materials.
• Write, review and revise SOPs.
• Perform/assist in internal assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Develop plans to correct identified risks and implement these plans.
• Maintain current and powerful expertise in quality systems and quality techniques. Maintain a high level of expertise in current regulatory requirements and technical issues.
• Assist in training staff and maintain training files.
• Perform equipment/process validation and/or equipment/process revalidation reviews.
• Implement company policies and assure conformance to specifications and plant procedures.
• Develop improved product sampling and measurement technology.
• Conduct defect/failure analysis on product as required.
• Perform process capability, and statistical process control studies on multiple product lines.
• Support Manufacturing and Quality Management with the development and implementation of new processes/technology.
• Assist in the identification and development of process improvement projects.
• Must have knowledge of both plant and department environmental health and safety regulations and follow said regulations accordingly.
• Must perform all other duties and responsibilities as determined by supervision/management.
• May include supervision of direct reports from multiple shifts

What you'll bring

• Bachelor’s degree in science (Any science..i.e. Chemistry, Biology, Micro)
• Exceptional organizational and technical problem-solving skills.
• Ability to manage multiple projects.
• Strong interpersonal skills and phenomenal attention to detail are necessary.
• Requires strong written and oral communication skills.
• Requires shift flexibility.
• Must have basic mathematical skills
• Meet visual acuity requirements as documented in Baxter Cleveland Visual Acuity procedure CL-01-01-037.
• Ability to lift, push, pull up to 25 pounds.
• Ability to climb on ladders
• Audiometric testing and hearing protection required
• Ability to work in u