Senior Quality Assurance Specialist

4 days ago

Cleveland, Ohio, United States BAXTER Full time
About This Role

We are seeking a highly skilled and experienced Senior Supplier Quality Assurance professional to join our team at Baxter. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and integrity of our products and processes.

Key Responsibilities
  • Initiate and issue SCARs (Supplier Corrective Action Requests) and RAMs (Risk Assessment and Mitigations) to ensure timely closure of quality records.
  • Own and manage SNCs (Supplier Notice of Changes) to maintain compliance with regulatory requirements.
  • Complete purchasing processes as the Supplier Quality Approver, ensuring adherence to quality standards.
  • Update, maintain, and approve all supplier-related information in the SQLM (Supplier Quality Lifetime Management) database.
  • Assess and communicate changes to local manufacturing processes, raw materials, or other mitigating factors to our customers, as applicable.
  • Perform other duties incidental to the above and assigned by supervisor.
Requirements
  • Bachelor's degree in a scientific field with 5-7 years of experience required or Master's degree in a scientific field with at least 5 years in a relevant subject area.
  • Requires 5+ years of experience in Quality, Manufacturing, Engineering, or a related field; cross-industry experience a plus.
  • Knowledge of pharmaceutical and/or medical device regulations, e.g. ISO 13485, ISO 14971, FDA cGMP, MDD, Eudralex, ICH Q series, other global or regional equivalent are preferred.
  • Auditing skills, up to and including certified Supplier Quality lead auditor training; Quality Management System auditing, and where possible, special process auditing skills. Experience auditing medical device and drug manufacturing facilities, preferred.
  • Experience in root cause analysis, corrective and preventive action methods; Expertise/experience in problem solving with quality tools such as 6-sigma / 8-D / CAPA / FMEA / 5WHY/ DMAIC etc. Experience in Product/process development and/or supplier quality improvement, preferred, Working understanding of production/quality development and control methods in healthcare industry.
  • Experience with data analysis and reporting using basic Excel toolkit. Advanced statistical /process packages such as Minitab or Visio and PowerPoint, preferred.
  • Collaboration and Teamwork: Good communications, facilitation, coordination and team skills.
  • Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions. Ability to prioritize and work with agility in a fast-paced environment.
  • Ability to manage the Quality relationship with assigned key suppliers/stakeholders is required.
What We Offer
  • Medical, Dental and Vision coverage
  • 160 hours of Paid Time Off and Paid Holidays
  • 401K match
  • Paid Parental Leave
  • Tuition Reimbursement
Equal Employment Opportunity

Baxter is an equal opportunity employer. We evaluate 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.

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