About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and an aesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

What You’ll Be Doing

It’s impossible to list everything you’ll do here because every day is different. But a few things are clear, you’ll:

Responsibilities:

1.Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, FDA cGMP, MDD, Eudralex, other global or regional equivalent

2.Workingknowledge of US and International cGMP for API and Excipients

3.Experiencein Product/process development and/or supplier quality improvement;

4.ForSQA with technical background, a good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control Plans, etc.

5.Auditingskillsets, up to and including certified SQ lead auditor training; Quality Management System auditing, and where possible, special process auditing skills

6.Knowledgeof Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business and organization

7.Collaborationand Teamwork: Good communications, facilitation, coordination and team skills

8.Projectmanagement skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions

9.Abilityto manage the Quality relationship with assigned key suppliers/stakeholders

10.Competencein supporting on-site/off-site supplier quality development including coordination/management of resources

11.Multi-taskingskills in a demanding fast paced environment

12.Superiortime-management skills

13.Attentionto details and a passion for quality

14.Superiorwritten and oral communications skill sets

15.Willingnessto travel (up to 40%)

Qualifications:

1.Bachelor's degree in a scientific discipline with 5-7 years of experience required or Master’s degree in a scientific discipline with at least 5 years in relevant discipline.

2.Requires5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus (e.g., automotive, aerospace, combination products, pharmaceuticals)

3.ForSQ Assurance Associates supporting drugs, Pharmaceutical Manufacturing experience is preferred

4.Experience auditing device and drug manufacturing facilities

5.Experiencein root cause analysis, corrective and preventive action methods;

6.Expertise/experience in problem solving with quality tools such as 6-sigma / 8-D / CAPA / FMEA /5WHY etc.

7.Experiencewith data analysis and reporting using basic Excel toolkit and advanced statistical /process packages such as Minitab or Visio and PowerPoint.

Why Baxter?

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

Apply today and experience a career that matters!

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