Quality Associate I

3 weeks ago

Irvine, United States BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

**Your Role at Baxter**

Responsible for managing, owning, evaluating and facilitating the nonconformance and CAPA quality system. Additional responsibilities including but not limited to: change control, complaint evaluations, data analysis and metrics reporting, identify/implement process improvements, lead projects, etc.

**What you'll be doing**
- Lead product and process improvement & NCR/CAPA projects with mínimal supervision, managing cross-functional teams to timely and effective closure.
- Perform root cause investigation analysis and data trending for NCR/CAPA.
- Manage project documentation in “TrackWise” system in compliance with Baxter practices and procedures.
- Perform monitoring of metrics in support of site and company goals and objectives.
- Support other teams in Investigation of customer complaints or internal events.
- Routinely own and support nonconformance investigations, root cause analysis, and CAPA.
- Coordinates quality system record owners and directs the activities associated with those systems.
- Responsible for NCR/CAPA Governance process and driving adherence to local and corporate targets.
- Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
- Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s).
- Serve as a backup for Complaints Handling - sample analysis, evaluation reports, data analysis, etc.
- Responsible for driving employee engagement through ownership of the behavior based quality program.
- May support other Quality System work - e.g. Change Control, Internal/External Audits, Improvement Projects - where needed.
- Identify and implement process improvements at the site and within own organization.
- Support the Quality organization and site in meeting business targets and metrics.

**What you'll bring**
- Bachelor’s degree in Engineering, Science or related field.
- 1-3 years of QA or Medical Device Operations experience.
- NCR/CAPA experience required.
- Experience with post-market surveillance/Complaints preferred.
- Experience leading projects/process improvements preferred.
- Requires scientific and technical knowledge in the areas of manufacturing, testing, documentation, and regulations.
- Thorough knowledge of applicable procedures, specifications, regulations and standards.
- Hands-on experience leading investigations & CAPA projects in regulated environment.
- Must be able to write clearly and informatively, edits work for spelling and grammar, presents numerical data effectively, able to read and interpret written information.
- Good presentation & communication skills
- able to speak clearly, listens and get clarification, present information to internal audience and regulatory body auditors.
- Good interpersonal/influencing/negotiation skills.
- Working knowledge of statistics and production processes.
- Understanding of quality principles related to medical device manufacturing.
- Working knowledge of FDA quality system regulations & cGMP.
- Working knowledge of TrackWise or similar system

LI-KV1

**Equal Employment Opportunity**

Baxter is an equal opportunity employer. Baxter evaluates 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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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