BAXTER & WOODMAN INC
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Quality Associate II
at BAXTER & WOODMAN INC
· Work with site leadership, conducts management reviews for the site.
· Responsible for reviewing pertinent documents, records and reports against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. Revise or review standard procedures.
· Identify areas of material and process non-conformance and inform management as needed to be disposed (unilaterally accepted or rejected) by others. NCRs and NCMRs may be initiated and addressed.
· Performs initial investigative actions on some NCRs, applying well-established techniques and procedures.
· Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.
· Support Supplier Quality responsibility for the site, and participate in supplier audit, as needed.
· Support negotiation and maintenance of Quality Agreements
· Provide Quality system training to site, and manage training assignments
· Support Quality system integration activities for new business acquisition
· Support Regulatory Submissions with direction from MCA RA manager
· Strong interpersonal skills and great attention to detail are necessary.
· Must be a strong team player with good problems solving, and good verbal and written communication skills.
· Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, and ISO 13485 standards, Application of Good Manufacturing Practices.
· BS in business/science or equivalent degree. 5-7 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.
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.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.