12 Quality Analyst I Jobs in Hayward, CA
Divihn Integration is Hiring a Quality Analyst I Near Hayward, CA
Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.
Please apply or call one of us to learn moreFor further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Meghna at 224 369 4230
Rashi at 630 847 1027Title: Quality Analyst I
Location: Hayward, CA
Duration: 3 MonthsDescriptionSummary
This position is responsible for supporting the batch release department. Responsibilities of the department include review and release of all batch production records. Provide quality support and guidance to all manufacturing groups.
Essential Duties And Responsibilities(List of Primary responsibilities of this role that account for 50% or more of the work. Incumbent may perform other duties as assigned.)
- Ensure timely QA review and release of in-process and finished goods documentation to verify compliance to SOPs and regulatory requirement.
- Write, revise and review SOPs.
- Perform QA on the floor activities (e.g. verifications, inspections, etc.).
- Ensure quality and consistency in documentation and adherence to SOPs.
- Maintain expertise in quality system (e.g. change control, critical system, etc.) and ability to initiate and execute change control requests.
- Assist with continuous improvement initiatives / projects.
- Participate in internal or external audits and support audit observations as needed.
- Ensure training requirements are met and records are up to date.
- Maintain and update departmental metrics and reporting.
- Work closely with the Manufacturing department to provide on-going Quality support.
- Represent QA at cross-functional meetings, providing QA input and decision making.
- Provide training to group and departments when needed.
- Assist department supervisor/manager with workload/activity scheduling
- Work with department supervisor/manager to identify and drive improve opportunities. Skill and knowledge with lean manufacturing tools and six sigma methodologies necessary to analyze and improve business processes.
- Must be very detail 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.).
- Application of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
- Demonstrated attention to details and accuracy, required.
- General knowledge of quarantine and warehouse operation helpful. May be required to work flexible hours, as needed.
Experience with applicable medical device (21CFR820, ISO 13485, CMDR, MDD) and/or biologics regulations desirable.
Physical Demands & Working Environment(The physical demands & working environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
- Regular attendance is necessary to perform the essential functions of the job.
- Light work, frequent lifting up to 40 lbs.; frequent standing/walking
- No travel required
- Normal office working conditions: computer, phone, files, fax, copier.
- Personal Protective Equipment: Latex-Free Gloves, safety shoes and safety goggles, as required.
Job Summary
Temporary
Business Services
08/04/2024
01/29/2025
divihn.com
HOFFMAN ESTATES, IL
50 - 100
2002
Private
ROOPA RAJESH
$10M - $50M
Business Services
Related Companies
The job skills required for Quality Analyst I include ISO, Microsoft Office, Initiative, Continuous Improvement, Attention to Detail, SOP, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Analyst I. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Analyst I. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Analyst I positions, which can be used as a reference in future career path planning. As a Quality Analyst I, it can be promoted into senior positions as a Building Inspector, Sr. that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Analyst I. You can explore the career advancement for a Quality Analyst I below and select your interested title to get hiring information.
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