Quality Assurance Analyst, Sr. - Healthcare jobs in San Jose, CA
Quality Assurance Analyst, Sr. - Healthcare analyzes quality assurance and compliance data and prepares reports. Designs solutions to quality management issues. Being a Quality Assurance Analyst, Sr. - Healthcare may assist in the implementation of quality improvement processes. May assist less experienced analysts. Additionally, Quality Assurance Analyst, Sr. - Healthcare requires a bachelor's degree. Typically reports to a supervisor or manager. The Quality Assurance Analyst, Sr. - Healthcare occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Quality Assurance Analyst, Sr. - Healthcare typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Quality Assurance Analyst, Sr. - Healthcare jobs
Sr. Manager, Quality Assurance
- Minerva Surgical
-
Santa Clara, CA
FULL_TIME
-
POSITION SUMMARY:
The Sr. QA Manager leads a team of Quality Engineer(s), Document Control Specialist(s), and Quality Assurance Specialists. The Sr. QA Manager is responsible for overseeing: material release, batch record review, and finish product release; document control and training; corrective/preventive actions, nonconforming products, complaint investigations; process deviations, rework, design control compliance, risk assessments, supplier audits, internal quality audits, quality records, trending of quality data, and management reviews.
DUTIES & RESPONSIBILITIES:- Provide technical guidance to Quality Engineers in review of manufacturing process and product design changes, validation and risk management activities and ensure that design control elements are met at all stages of product development.
- Lead the implementation of company improvement projects, e.g., implementation of electronic Document Control and Training modules in our QMS system from a paper-based system.
- Lead and/or help coordinate regulatory audits and internal audits of Minerva’s QMS.
- Provide oversight of Minerva’s supplier audit program
- Manage the Corrective and Preventive Action process to guide the organization on the path of continuous improvement. Oversee quality data trending activities. Help prepare and present periodic CAPA Council and Management Review presentations.
- Manage the Document Control system to ensure changes to quality system documents are in accordance with regulations/procedures.
- Provide training in aspects of quality assurance, internal procedures and current Good Manufacturing Practices.
- Write, implement, and/or approve changes to controlled documents (e.g. SOPs, specifications, protocols, reports, manufacturing procedures, etc.) as needed.
- Ensure adherence to internal procedures for cGMP production in accordance with ISO 13485:2016, and FDA QSR.
- Manage QA staff, with oversight for quality assurance responsibilities:
- Ensure timely review and approval of manufacturing batch records, inspection records, nonconformance reports, to facilitate product release and demonstrate compliance to governing regulations and internal procedures.
- Investigate and close customer complaints
- Process NCRs, CAPAs, SCARs, Out of Tolerance Reports, Environmental Excursions, Customer Complaints, Returned Goods Authorization; maintain logs or master lists, and publish/scan approved documents onto company network.
- Ensure employees are trained to current revision documents, and that training records are maintained.
- Process and maintain ECOs, approved documents, and quality records and logs in Document Control.
- Ensure ongoing compliance with external standards and regulations.
Preferred Requirements:- ASQ Certified Quality Engineer.
- ASQ Certified Quality Auditor/Biomedical Auditor
- Understanding of Medical Device Risk management.
- Ability to work well under pressure, to handle multiple projects, and to meet aggressive deadlines.
- Ability to read and understand and implement to compliance regulations, standards and procedures.
- Ability to perform statistical analysis of data.
- Good leadership, analytical and interpersonal skills.
- Exceptional attention to detail and organizational skills.
- Exceptional project management and team building skills.
- Effective verbal and written communication skills.
- Proficient in use of MS Word, MS Excel, PowerPoint is required.
- Proficient use of Visio flowcharting preferred.
Preferred Education and/or Job experience:- Minimum of a Bachelor's degree, preferably in a scientific or technical field, as well as 10 years direct quality engineering and quality assurance experience within the commercial medical device industry.
- 5 years of Quality Management experience
- Experience in start-up and mid-size company environments.
- Experience with product transfers and integrations from product acquisitions a plus.
- Working knowledge of current ISO 13485:2016, and FDA QSR.
- 2 Days Ago
Sr Quality Assurance Engineer
- Telos Health, Inc.
-
Campbell, CA
FULL_TIME
- Job Title: Senior Quality Assurance EngineerLocation: This position is based in our Campbell, California offices. Why Telos Health?At Telos Health we are developing novel robotic-assisted technologies...
- 2 Months Ago
Healthcare Compliance Sr. Analyst
- Recor Medical
-
Palo Alto, CA
FULL_TIME
- At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a m...
- 3 Days Ago
Healthcare Compliance Sr. Analyst
- Recor Medical
-
Palo Alto, CA
FULL_TIME
- At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a m...
- 3 Days Ago
Sr. Quality Assurance Specialist (GLP)
- AMADOR BIOSCIENCE INC
-
Pleasanton, CA
FULL_TIME
- Amador Bioscience (AmadorBio) is a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regu...
- 2 Months Ago
Sr Manager, CMC Quality Assurance
- Kaztronix
-
Menlo, CA
FULL_TIME
- Company is seeking a Senior Manager, CMC Quality Assurance, to help lead quality for Company's Client oncology therapies. The Senior Manager of CMC Quality Assurance will be responsible for building t...
- 27 Days Ago
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0 Quality Assurance Analyst, Sr. - Healthcare jobs found in San Jose, CA area
Content Management Specialist (Tech QA Analyst)
- WPP PLC
-
San Jose, CA
- Who We Are At VML, we are a beacon of innovation and growth in an ever-evolving world. Our heritage is built upon a cent...
- 5/1/2024 12:00:00 AM
Quality Assurance Manager
- PSG Global Solutions
-
Santa Clara, CA
- Type of Requisition: Casual Clearance Level Must Be Able to Obtain: None Public Trust/ Other Required: None Job Family: ...
- 5/1/2024 12:00:00 AM
Business Systems Analyst
- eXcell
-
San Jose, CA
- has been staffing IT professionals at the top Fortune 100 companies for over two decades. Whether you are looking for a ...
- 5/1/2024 12:00:00 AM
Business Systems Analyst
- Ampcus Incorporated
-
San Jose, CA
- Objective: Client is seeking an individual to join the Technology Services team and perform system configuration, custom...
- 5/1/2024 12:00:00 AM
100% Remote - QNXT Benefits Configuration Analyst
- Beacon Hill
-
San Jose, CA
- NOTE: This is a 100% remote position. Candidates will have to work on EST hours. One of our clients in Norfolk, Virginia...
- 5/1/2024 12:00:00 AM
Inventory Control & Quality Assurance Analyst
- Weee!, Inc.
-
Milpitas, CA
- **Inventory Control & Quality Assurance Analyst** at Weee! Inc Milpitas, California, United States ****About Weee!**** a...
- 4/29/2024 12:00:00 AM
JUNIOR MANUAL QA ANALYST - CONTRACT - REMOTE - USC OR GC NO C2C NO C2H
- System Soft Technologies
-
San Jose, CA
- MANUAL QA TESTER - CONTRACT TO HIRE - REMOTE EASTERN TIME ZONE ONLY - USC , GC, NO C2C We seek a MANUAL QA TESTER for a ...
- 4/28/2024 12:00:00 AM
Business Intelligence - REMOTE - Candidates must be near Malvern PA - 1 day a month on-site Contract W2 ONLY
- Calance
-
San Jose, CA
- Position: Business Intelligence Location: REMOTE Rate: $45-$57 per hour W2 Business Intelligence QA Analyst I Duties: Re...
- 4/28/2024 12:00:00 AM
About San Jose, California
San Jose is located at 37°20′07″N 121°53′31″W / 37.335278°N 121.891944°W / 37.335278; -121.891944. According to the United States Census Bureau, the city has a total area of 180.0 sq mi (466 km2), of which 3.4 sq mi (8.8 km2) (1.91%) is water, making it the fourth-largest California city by land area (after Los Angeles, San Diego and California City).
San Jose lies between the San Andreas Fault, the source of the 1989 Loma Prieta earthquake, and the Calaveras Fault. San Jose is shaken by moderate earthquakes on average one or two times a year. These quakes originate just east of the city on...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Analyst, Sr. - Healthcare jobs
$99,012 to $127,862
San Jose, California area prices
were up 2.9% from a year ago
were up 2.9% from a year ago