8 Quality Assurance Analyst Jobs in Oakland, CA
BioTalent is Hiring a Quality Assurance Analyst Near Oakland, CA
Quality Assurance Analyst
EU-MDR Post-Market
Regulation (EU) 2017/745
Responsibilities:
- Manage manufacturing batch records/DHRs using eQMS with Technical Operations and an overseas Contract Manufacturer.
- Handle medical device complaints and vigilance reports per US FDA and EU MDR; experience with other MDSAP regions preferred.
- Manage and report on CAPAs; collaborate with CAPA owners; chair monthly CAPA meetings.
- Work with EU MDR entities (Competent Authority, Notified Body, Importer/Distributor, Authorized Representative).
- Administer EUDAMED, FDA GUDID, and GTIN databases.
- Write EU-MDR Post Market documentation (PMSP, PSUR, Trend Reports).
- Assist Head of Quality with QMS tasks (dashboards, eQMS training).
Requirements:
- 5-10 years experience with Medical Device QMS (ISO13485:2016) and EU MDR (Regulation (EU) 2017/745).
- Experience writing EU MDR Post Market documentation.
- Experience with eQMS (superuser/administrator preferred).
- Attention to detail and diligence in scheduled tasks.
- Experience with SaMD and medical database products preferred.
- Experience with MDSAP, UKCA, and EMEA regulations preferred.
Job Summary
Full Time
$75k-92k (estimate)
07/07/2024
07/20/2024
The following is the career advancement route for Quality Assurance Analyst positions, which can be used as a reference in future career path planning. As a Quality Assurance Analyst, it can be promoted into senior positions as a Quality Assurance Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Analyst. You can explore the career advancement for a Quality Assurance Analyst below and select your interested title to get hiring information.
If you are interested in becoming a Quality Assurance Analyst, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Assurance Analyst for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Quality Assurance Analyst job description and responsibilities
A QA Analyst establishes a process to monitor all the activities and tasks to release high-quality service.
01/14/2022: Topeka, KS
A quality assurance analyst also assesses a business to determine problems that affect overall quality.
03/04/2022: Kansas City, KS
A quality assurance analyst evaluates products, systems, and software to ensure they are free of defects and meet the quality standards of the organization.
01/04/2022: Akron, OH
QA analysts use processes that ensure the quality of the product and service meets the requirements of the product creators, service providers, and customers.
12/27/2021: Clearwater, FL
Quality assurance analysts document the entire quality testing process.
01/09/2022: Fort Wayne, IN
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Assurance Analyst jobs
Good quality assurance analysts ensure standards are maintained during production to provide top quality products for consumers, all the time, every time.
03/06/2022: San Antonio, TX
The roles and responsibilities of a Quality Assurance Analyst focus on total quality management.
03/09/2022: Lexington, KY
Most employers use applications to test products and services, and it is a plus if a quality assurance analyst is familiar with one or several of those applications.
01/22/2022: Lima, OH
A good QA analyst must be able to spot trends and tendencies within the data.
02/18/2022: Portland, ME
Those who aspire to become a quality assurance analyst should acquire enough experience and expertise in certain field.
02/22/2022: Laramie, WY
Step 3: View the best colleges and universities for Quality Assurance Analyst.
