Coordinate the receipt and evaluation of product complaint samples. Entry of customer complaints into the PIR database. Maintain QA complaint files. Purchase supplies and maintain mail accounts. Perform initial sample evaluation and coordinate investigation of root cause for PI - Rs. Follow up on evaluation status and assist in preparing a weekly status report. Assist in Drafting customer response letters for all products. Ability to retrieve information on customer orders, product stock and par... more details
QA Prod Incident Report Technician I
Job LocationsUS-CA-Irvine
Requisition ID
2024-24229
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
Mon-Fri 7:30AM-4:00PM
Site
Irvine, CA
Overview
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
Responsibilities
Position Summary:
Coordinate the receipt and evaluation of product complaint samples. Entry of customer complaints into the PIR database. Maintain QA complaint files. Purchase supplies and maintain mail accounts. Perform initial sample evaluation and coordinate investigation of root cause for PIRs. Follow up on evaluation status and assist in preparing a weekly status report. Assist in Drafting customer response letters for all products. Ability to retrieve information on customer orders, product stock and part number traces in SAP. Assist in Identifying potential Adverse Drug Experiences and Medical Device Reports and take appropriate action. Perform basic analyst duties in the absence of the analyst.
Responsibilities: Essential Duties
Performs preliminary complaint investigation and prepares investigation reports.
Ensures effective and timely manner in handling of the complaint in accordance to the complaint management procedures.
Ensures complaint samples are archived as per required and maintain records.
Attends meetings pertaining to complaint as and when required.
Performs other routine administrative activities according to the organization's established procedures.
Ensures the safety and care of the complaint laboratory and test equipment.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General:
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
Expertise: Knowledge & Skills
Assignments are routine and repetitious in nature. Work performed within narrowly defined parameters. Follows established procedures and guidelines.
Works under direct supervision and from detailed verbal and/or written instructions. Uses established procedures to accomplish assigned task.
May require some limited judgement in resolving problems.
Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
High school diploma/G.E.D or equivalent required, Associate's or technical degree preferred.
0-02 years related experience required.
Regular and predictable on-site attendance
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
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Additional Information
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
While performing the duties of this job, the employee is expected to:
Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Lifting, Carrying, Pushing, Pulling and Reaching:
Occasionally:Reaching upward and downward, Push/pull
Frequently:Stand, Sit, Visual Acuity with or without corrective lenses
Constantly:N/A
Activities:
Occasionally:Handling, Push/pull, Reaching upward and downward
Frequently:Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing, Talking - ordinary, loud/quick, Walking
Constantly:N/A
Environmental Conditions:
Occasionally:N/A
Frequently:Other
Constantly:N/A
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Notices
Equal Opportunity Employer Veterans/Disabled
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