B. Braun Medical Inc. (US) · 1 day ago
Prod Incident Rpt Tech I
Irvine, CA
Full-time
Onsite
New Grad, Entry Level
$24/hr - $26/hrB. Braun Medical Inc., a leader in infusion therapy and pain management, develops innovative medical products and services for the healthcare industry. The Prod Incident Rpt Tech I will coordinate the receipt and evaluation of product complaint samples, manage the PIR database, and assist in quality investigations and reporting.
BiotechnologyMedical DeviceEducationHealthcareManufacturingPharmaceuticalClinical TrialsHealth Care
Responsibilities
Receive product complaints and samples from such sources as customers, sales representatives, distributors and FDA. Enter complaints into the computerized Product Incident Report (PIR) database (access/informix database) to ensure their traceability
Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures
Unpack, identify and organize returned complaint samples and assist in performing initial inspection of such samples. The incumbent must follow the guidelines for handling of human blood and other body fluids with all samples in order to avoid risk of contamination. Forward samples to Purchased Finished Good manufacturers or PA also as applicable
Maintain the QA complaint master files, ensuring all complaint files are present and that complete information is recorded for each complaint. Include storage of files on and off site
Determination of routing for complaint samples to different functional areas in the plant for investigation
Track the receipt of complaint samples and notify the QA Analyst of samples that are overdue
Purchase supplies required for safe handling of complaint samples and any supplies necessary for maintenance of files, laboratory equipment, etc. Also maintain accounts at the Post Office
Coordinate investigation of root cause analysis for complaints with Business Units or other areas as required
Prepare draft response letters for all complaints with review by the Analyst
Prepare weekly PIR summary running access queries and tracking data in Excel spreadsheet. Graph data. Also run or create access reports to pull requested data from PIR database
Run SAP searches for customer order histories, available stock of product and backwards and forward part number traces as required
Coordinate outside PIR lab activities and follow up for investigations
Identify potential Adverse Drug Experiences and Medical Device Reports as PIRs are received and notify QA Analyst or QA Manager. Assist in preparation of MDR reports for submission to FDA
Identify any trends on incoming reports or investigation results and notify QA Analyst or QA Manager
Qualification
Required
Associates Degree or a Bachelor's Degree in related field
Hepatitis B immunization
Antibiotic and respiratory screening for Duplex plant
Thorough knowledge of the proper handling skills for potentially infectious samples is required
Understanding of documentation procedures and GMPs for the health care industry
Thorough knowledge of medical/pharmaceutical products
Good understanding of CFRs for ADEs and MDRs
Proficiency with computers (Access, Word, Excel)
Ability to perform general physical tests on returned samples
Excellent written and verbal communication skills
Excellent organizational skills
Demonstration of good decision making skills
Ability to identify trends in reports or investigation results
Ability to complete tasks within a specific time frame
Ability to be self motivated and work independently
Detail oriented
Preferred
Experience in the biotech or pharmaceutical industry
Benefits
Healthcare
401(k) plan
Tuition reimbursement
Company
B. Braun Medical Inc. (US)
B.
Founded in 1839
10001+ employees
H1B Sponsorship
B. Braun Medical Inc. (US) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (10)
2023 (14)
2022 (6)
2021 (12)
2020 (9)
Funding
Current Stage
Late StageTotal Funding
$0.03MKey Investors
Ben Franklin Technology Partners of Northeastern Pennsylvania
2020-10-27Debt Financing· $0.03M
Leadership Team
Leigh Ann Stradford
Senior Vice President and Chief Human Resources Officer
Rob Albert
Senior Vice President and Chief Marketing Officer/ Senior Vice President of Marketing
Recent News
The Morning Call
2026-02-03
2026-02-02
2026-01-15
Company data provided by crunchbase