the smart solution for Bethlehem jobs

Senior Quality Assurance Specialist, Complaints

Company: Aesculap Inc.
Location: Bethlehem
Posted on: March 14, 2019

Job Description:


Requisition ID 2018-12875
Company Aesculap Inc
# of Openings 1
Job Locations US
Category Quality
Position Type Regular Full-Time
Shift 8am -5 pm
Site Aesculap


Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients' lives.


Position Summary:

The Senior QA Specialist, Complaints, is responsible for verification of Complaint and MDR content, including determination of medical review escalation, within the Complaint Handling Unit

Responsibilities: Essential Duties

Evaluates information received by AIC and AIS customers, Sales, Marketing, Customer Service, Aesculap Technical Services or any other source of product or service complaint.
Enters information and data into complaint handling system as appropriate.
Verifies that communication and investigation data is recorded in complaint files appropriately within the system.
Evaluates complaints for adverse event reporting as applicable. Verifies decisions for "Vigilance report not required" determinations.
Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA.
Within complaint system, acts as Safety Officer for adverse event reporting purposes.
Based on assessed risks, coordinates the escalation to Medical Reviewer(s) for decisions regarding the potential for serious injuries.
As applicable, communicates with sales representatives and customers to coordinate return of complaint product and obtain additional information as necessary.
As applicable, evaluate returned complaint product and conduct follow up as required.
Triggers local complaint investigations as appropriate (e.g., complaints on service repairs or loaner set distribution) and supports those investigations as requested.
Monitors and reports on progress of complaint investigations from OEM, contract manufacturers or other third party suppliers.
Monitors, evaluates, and reports on complaint product, and internal investigation.
Runs complaint reports as requested.
Trains personnel on complaint handling and adverse event reporting as required.
Supports other Quality related activities as assigned.
Acts as informal resource for colleagues with less experience
Must comply with applicable ISO and FDA regulations as stated in Quality Manual
Must embody the Company's Vision, Mission and Values
Other duties may be assigned.

Expertise: Knowledge & Skills

Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.



Valid Nursing license/credential (RN or LPN/LVN preferred). Associates degree or higher in an applicable field (nursing, life sciences, or engineering preferred).
Requires 3+ years experience documenting customer complaints. Prefer 2+ years experience reviewing US Vigilance Reports (MDRs) within the medical device industry.
Requires high level of attention to detail (for database entry and content review).
Requires working knowledge of database applications (SAP preferred)
Requires working knowledge of document control systems (Bdocs preferred)
Requires knowledge of 21 CFR 820 (Quality System Regulations), 21 CFR 803 (Medical Device Reporting), and 21 CFR 1271.350 (HCT/P Reporting), and Good Manufacturing Practices (GMP)
Requires high level of computer proficiency.
Requires good communication skills (over the telephone, in person, and in writing)


Preferred: Internal Auditor certification (ASQ-CQA, or ISO 13485 lead auditor certification.
Preferred: experience participating, and leading, CAPA investigations


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:

The physical demands 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.

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. This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.

The noise level in the work environment is usually moderate. PI108143046 Pandologic. Keywords: Quality Control / Quality Assurance Specialist, Location: Bethlehem, PA - 18018

Keywords: Aesculap Inc., Bethlehem , Senior Quality Assurance Specialist, Complaints, Other , Bethlehem, Pennsylvania

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Other Jobs

Proofreader - Work From Home
Description: What We Do We are experts in the emerging field of customer experience measurement and improvement. Our solutions help brands make sure they are consistently delighting their customers at all touch-points, (more...)
Company: Mommy Jobs Online
Location: Hicksville
Posted on: 03/23/2019

Customer Care Representative:. English and Bilingual
Description: Customer Care Representative English and Bilingual Mommy Jobs Online is now seeking Customer Care Representatives. Working at home can be an ideal situation from saving you money (more...)
Company: Mommy Jobs Online
Location: White Plains
Posted on: 03/23/2019

Police Officer Exam
Description: Police Officer Exam City of White Plains Police Officer Exam 50,000- 93,834 Apply now through April 25, 2019Exam Date: November 23, 2019 Women, Minorities and Veterans are
Company: Confidential
Location: White Plains
Posted on: 03/23/2019

Claim Rep Trainee Outside Prop Lancaster
Description: Claim Rep Trainee Outside Prop Lancaster, 19672BR, Lancaster, PA, USMenu ToggleMenu Hide Home Life at Travelers About Us The Travelers Experience Why Travelers Community Involvement Benefits Diversity (more...)
Company: Travelers Insurance
Location: Lancaster
Posted on: 03/23/2019

Claims Assistant
Description: Claims Assistant br br Harrisburg, PA br br POSITION SUMMARY: Under close supervision performs clerical and data entry tasks that assist in administration of workers' compensation claims. This (more...)
Company: Cameron Craig Group
Location: Harrisburg
Posted on: 03/23/2019

Current College Students - Stores Executive Intern - Baltimore Metro Area
Description: One of the world's leading and most recognized brands comes to life in our stores, where guests are still captivated by everything that made them fall in love with Target. Our approximately 1800 locations (more...)
Company: Target
Location: Harrisburg
Posted on: 03/23/2019

"Guide" Telephone Representative (Remote)
Description: Join ASSURANCE, and access our leading edge selling platform as an independent call concierge. br br The Guide telephone representative is responsible for ensuring our customers get the insurance (more...)
Company: Assurance Wireless
Location: Harrisburg
Posted on: 03/23/2019

Cosmetics and Beauty Hiring Event - Mar 26, 11am-7pm: Broadway Mall
Description: Macy's Cosmetics Hiring Event Tuesday, March 26th - 11:00 a.m. to 7:00 p.m. Macy's will be conducting on-the-spot interviews and extending job offers for open positions. Complete your application and (more...)
Company: Macy's
Location: Hicksville
Posted on: 03/23/2019

Want to Supplement Your Income? (Telecommute)
Description: We are currently interviewing for Benefit Consultants for the nation's largest provider
Company: JMS Benefits
Location: Lancaster
Posted on: 03/23/2019

Law Enforcement Transcription
Description: Law Enforcement Transcription Vendors / independent contractors who can transcribe audio content of criminal investigations, internal affairs, and various law enforcement audios. Contractors must have (more...)
Company: Mommy Jobs Online
Location: Harrisburg
Posted on: 03/23/2019

Log In or Create An Account

Get the latest Pennsylvania jobs by following @recnetPA on Twitter!

Bethlehem RSS job feeds