Baxter Quality Engineer Vacancy – Biological Science Job Opening
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.
Job Title: Sr Quality Engineer
Req #: JR – 081048
Location Hayward, California, United States
Job Category: Engineering
Education/Experience
•BS in Biological Science or equivalent
•5-10 Years in Quality a pharmaceutical or medical device organization or a similarly regulated industry. Other relevant experience outside of Quality but in a regulated industry may be considered.
Industry. Experience with applicable medical device (21CFR820, ISO13485, CMDR, MDD) and/or biologics regulations desirable
Knowledge/Skills/Abilities
•Must be very detailed oriented with a high quality of work
•Knowledgeable in current Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
•Working knowledge of FDA regulations (Part 820, 211), ISO 13485, and other applicable regulations.
•Must demonstrate effectiveness in ability to train others, drive results, and meet deadlines.
Proficient in Microsoft Office applications (e.g. Word, Excel, etc)
•Regular attendance is necessary to perform the essential functions of the job.
• Light work, may require lifting; extended period of sitting/standing.
•No travel required
•Normal office working conditions: computer, phone, files, fax, copier.
Personal Protective Equipment: safety glasses as required
This position is responsible for providing Quality support in process improvements, compliance projects and manufacturing support. Identify and assess regulatory and quality risks in manufacturing activities and processes per regulatory agency guidelines and Baxter quality policies.
•Lead continuous improvement projects focused on manufacturing and quality processes.
•Perform data and statistical analysis.
•Act as local Quality support on new product launch or geographic expansion initiatives.
•Write, review, and approve validation/manufacturing protocols and reports, technical documents, etc.
•Write, review, analyze and revise written Standard Operating Procedures (SOPs), Batch Records, and other documents and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
•Lead and assist in non-conformance investigations.
•Perform gap assessment on manufacturing and quality processes.
•Support Change Control, NCR, CAPA, Management Review, Corporate Holds, Field Corrective Actions, or other quality systems, as assigned
Participate in multi-site Quality projects in the role of contributor, coordinator or lead.
Baxter Quality Engineer Vacancy
