Sr Manager, Quality Assurance Job at Baxter (Cleveland)

Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility

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

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
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
Applicants must be authorized to work for any employer in the U.S. We cannot sponsor or transfer sponsorship of an employment visa.

Nice to have

FDA regulated manufacturing experience preferred
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

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
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
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits

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Sr Manager, Quality Assurance

Job Description

Job Responsibility

Requirements

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What we offer

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