BethlehemRecruiter
the smart solution for Bethlehem jobs

Senior Quality Assurance Specialist, Complaints

Company: Aesculap Inc.
Location: Bethlehem
Posted on: November 4, 2018

Job Description:

Aesculap Inc.Requisition ID 2018-12875Company Aesculap Inc# of Openings 1Job Locations USCategory QualityPosition Type Regular Full-TimeShift 8am -5 pmSite AesculapOverview

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.

Responsibilities

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.


      Qualifications

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

          Other

          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.

          PI105301640

          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
          within


Other Other Jobs


Accounts Receivable Administrator
Description: Accounts Receivable Administrator US-PA-Bensalem Requisition ID: 2018-1556719020-2028 Overview Healthcare Services Group HCSG is currently seeking to fill the position of Accounts Receivable Administrator (more...)
Company: Healthcare Services Group, Inc.
Location: Bensalem
Posted on: 11/20/2018

Professional Landscapers - Grow Your Business With HomeAdvisor (Levitt
Description: Professional Landscapers - Grow Your Business With HomeAdvisor Levitt Over 25 million homeowners
Company: HomeAdvisor
Location: Levittown
Posted on: 11/20/2018

Current College Students - Part-Time Interface Designer with UI/UX Expertise
Description: Responsible for producing interactive
Company: BrawtaSports Network
Location: Philadelphia
Posted on: 11/20/2018


Systems Engineer
Description: Overview Every day at Perspecta, we enable hundreds of thousands of people to take on our nation's most important work. We're a company founded on a diverse set of capabilities and skills, bound together (more...)
Company: Perspecta
Location: King Of Prussia
Posted on: 11/20/2018

Personal Banker Registered 2 (Sicklerville,NJ)
Description: Job Description br At Wells Fargo, we want to satisfy our customers financial needs and help them succeed financially. We re looking for talented people who will put our customers at the center of everything (more...)
Company: Wells Fargo
Location: Sicklerville
Posted on: 11/20/2018

Scheduling Inteviews - Work From Home
Description: We are seeking upbeat and motivated individuals to join our award winning team. This is a solid company that offers top
Company: Professional Home Career Advantage
Location: Philadelphia
Posted on: 11/20/2018

CLEANER SEASONAL MUST PASS DRUG TEST
Description: ABM, a leading provider of integrated facility solutions, is looking for a Cleaner.The Cleaner provides
Company: ABM Industries
Location: Swedesboro
Posted on: 11/20/2018

OTR & Regional Truck Drivers, Make $80,000+ Yearly!
Description: Call Our Recruiters at 800-240-1703 today CDL-A Company Truck Driver Refrigerated OTR Company Driver Smart and safe drivers earn 80,000 plus yearly Florilli Transportation is a family owned and operated (more...)
Company: Florilli Transportation
Location: Chester
Posted on: 11/20/2018

Sitter Wanted - Philadelphia, Pennsylvania Child Carer Job
Description: Job Description: br I hope you are having a good day. I'm interviewing a night nanny available in Philadelphia,
Company: Sitter
Location: Philadelphia
Posted on: 11/20/2018

Premier Banker 1
Description: Job Description br At Wells Fargo, we want to satisfy our customers financial needs and help them succeed financially. We re looking for talented people who will put our customers at the center of everything (more...)
Company: Wells Fargo
Location: Philadelphia
Posted on: 11/20/2018

Log In or Create An Account

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

Bethlehem RSS job feeds