Baxter Quality Engineer Vacancy – Biological Science Job Opening
Baxterโs 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
โขBS in Biological Science or equivalent
โข5-10 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
โขMust be very detailed oriented with a high quality of work
โขKnowledgeable in current Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
โขWorking knowledge of FDA regulations (Part 820, 211), ISO 13485, and other applicable regulations.
โขMust demonstrate effectiveness in ability to train others, drive results, and meet deadlines.
Proficient in Microsoft Office applications (e.g. Word, Excel, etc)
โขRegular attendance is necessary to perform the essential functions of the job.
โข Light work, may require lifting; extended period of sitting/standing.
โขNo travel required
โขNormal 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.
โขLead continuous improvement projects focused on manufacturing and quality processes.
โขPerform data and statistical analysis.
โขAct as local Quality support on new product launch or geographic expansion initiatives.
โขWrite, review, and approve validation/manufacturing protocols and reports, technical documents, etc.
โขWrite, 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.
โขLead and assist in non-conformance investigations.
โขPerform gap assessment on manufacturing and quality processes.
โขSupport 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
