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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.
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
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
Nice to have:
FDA regulated manufacturing experience
Six Sigma Green Belt Certification or industry-standard equivalent
Project Management skills and experience
Experience and skills in Lean Manufacturing
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)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service