Mgr II, Quality Assurance - Solutions

Baxter • Cleveland, OH

7d • $136,000 - $170,000

About The Position

As the Manager II, Quality Assurance - Solutions, you will lead all aspects of Devices Quality operations and manage staff in this area. You will direct, coordinate, and evaluate the unit's work, ensuring activities follow company policies and legal requirements. You will also lead initiatives to improve processes and maintain compliance with standards, ensuring our products meet quality expectations.

Requirements

• Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering, or equivalent experience, required.
• 5+ years of Engineering/Manufacturing/Quality experience required, with 3-5 years of leadership experience.
• FDA regulated manufacturing experience preferred.

Nice To Haves

• Six Sigma Green Belt Certification or industry-standard equivalent preferred.
• Project Management skills and experience are preferred.
• Experience and skills in Lean Manufacturing are preferred.

Responsibilities

• Lead quality oversight for the Devices areas.
• Develop, assign, and implement systems, procedures, and policies to ensure compliance with ISO Standards, cGMP's, FDA regulations, and company policies.
• Conduct audits and implement changes to specifications, SOPs, and forms for regulatory compliance and process improvement.
• Ensure product compliance through established inspection criteria and procedures.
• Coordinate inspection activities throughout the production cycle.
• Analyze statistical data and product specifications to determine and improve quality standards.
• Prepare and submit reports to Managers and other Departments or Agencies as required.
• Communicate quality philosophy to key personnel.
• Actively participate in quality management teams within the organization.
• Manage and support area associates, encouraging a teamwork environment.
• Train and integrate new engineers, associates, and technicians.
• Drive quality/manufacturing projects using Lean, problem-solving, process control, and project management tools.
• Maintain comprehensive knowledge of plant systems, processes, procedures, documentation, and products.
• Evaluate and implement system changes per Baxter procedures.
• Lead and establish effective working teams.
• Manage and prioritize multiple tasks and projects.
• Ensure effective communication in both written and verbal forms.
• Coordinate financial goals and budgets for departments.
• Promote company security, industrial hygiene, cGMPs, and other established policies.
• Perform tasks independently with minimal supervision.
• Travel as needed to fulfill duties.

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: Manager