21 days old

Senior Quality Assurance Specialist, Complaints

Aesculap Inc.
Center Valley, PA 18034
  • Job Code
    112440477
Aesculap Inc.


Senior Quality Assurance Specialist, Complaints

US-PA-Center Valley

Job ID: 2019-14953
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Aesculap Inc.

Overview

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:

  • Bachelors degree or higher in an applicable field (nursing, life sciences, or engineering). (BSN with nursing license preferred, RN with nursing license & Associate degree acceptable).
  • Requires 4+ years’ experience documenting customer complaints(may be waived for applicant with Nursing License).
  • Requires high level of attention to detail (for database entry and content review).
  • Requires working knowledge of complaint 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 Good Manufacturing Practices (GMP)
  • Requires high level of computer proficiency.
  • Requires good communication skills (over the telephone, in person, and in writing)

Desired:

  • Prefer 3+ years’ experience reviewing US Vigilance Reports (MDRs) within the medical device industry.
  • Preferred: Internal Auditor certification (ASQ-CQA, or ISO 13485 lead auditor certification)
  • Preferred: experience participating, and leading, CAPA investigations

PI112440477

<b>Aesculap Inc.</b><br/><br/><br/><b>Senior Quality Assurance Specialist, Complaints</b><br/><br/>US-PA-Center Valley<br/><br/><b>Job ID:</b> 2019-14953<br/><b>Type:</b> Regular Full-Time<br/><b># of Openings:</b> 1<br/><b>Category:</b> Quality<br/>Aesculap Inc.<br/><br/><b>Overview</b><br/><br/><p style="margin: 0in 0in 0pt;"><span style="color: black; font-family: tahoma,arial,helvetica,sans-serif; font-size: 10pt;">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.</span></p><br/><br/><b>Responsibilities</b><br/><br/><p style="margin: 0in 0in 0pt;"><strong><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;">Position Summary:</span></strong></p><p style="margin: 0px;"><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">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.</span></p><p style="margin: 0in 0in 0pt;"><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;"> </span></p><p style="margin: 0in 0in 0pt;"><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;"><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;"><strong><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;">Responsibilities: Essential Duties</span></strong></span></span></p><ul><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Evaluates information received by AIC and AIS customers, Sales, Marketing, Customer Service, Aesculap Technical Services or any other source of product or service complaint.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Enters information and data into complaint handling system as appropriate.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Verifies that communication and investigation data is recorded in complaint files appropriately within the system.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Evaluates complaints for adverse event reporting as applicable. Verifies decisions for Vigilance report not required determinations. </span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Within complaint system, acts as Safety Officer for adverse event reporting purposes. </span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Based on assessed risks, coordinates the escalation to Medical Reviewer(s) for decisions regarding the potential for serious injuries. </span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">As applicable, communicates with sales representatives and customers to coordinate return of complaint product and obtain additional information as necessary. </span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">As applicable, evaluate returned complaint product and conduct follow up as required.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Triggers local complaint investigations as appropriate (e.g., complaints on service repairs or loaner set distribution) and supports those investigations as requested.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Monitors and reports on progress of complaint investigations from OEM, contract manufacturers or other third party suppliers.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Monitors, evaluates, and reports on complaint product, and internal investigation.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Runs complaint reports as requested.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Trains personnel on complaint handling and adverse event reporting as required.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Supports other Quality related activities as assigned.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Acts as informal resource for colleagues with less experience</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Must comply with applicable ISO and FDA regulations as stated in Quality Manual</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Must embody the Companys Vision, Mission and Values</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Other duties may be assigned</span></li></ul><p style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 12pt;"><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;"><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;"><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;"><strong><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;">Expertise: Knowledge & Skills</span></strong></span></span></span></p><ul><li><div style="color: #000000;"><span style="font-family: tahoma,arial,helvetica,sans-serif; font-size: 10pt;"><span style="font-family: tahoma,arial,helvetica,sans-serif; font-size: 10pt;"><span style="text-decoration: underline;">Language Skills:</span> 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. </span></span></div></li><li><span style="font-family: tahoma,arial,helvetica,sans-serif; font-size: 10pt;"><span style="text-decoration: underline;"><span style="font-family: tahoma,arial,helvetica,sans-serif; font-size: 10pt;"><span style="text-decoration: underline;">Mathematical Skills:</span></span></span><span style="font-family: tahoma,arial,helvetica,sans-serif; font-size: 10pt;"> 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.</span></span></li><li><div style="margin: 0in 0in 8pt;"><span style="font-family: tahoma,arial,helvetica,sans-serif; font-size: 10pt;"><span style="text-decoration: underline;">Reasoning Ability:</span> 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.</span></div></li></ul><div><p style="margin: 0in 0in 0pt;"> </p></div><br/><br/><b>Qualifications</b><br/><br/><p style="margin: 0in 0in 0pt;"><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;"><strong><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;">Required:</span></strong></span></p><ul><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Bachelors degree or higher in an applicable field (nursing, life sciences, or engineering). (BSN with nursing license preferred, RN with nursing license & Associate degree acceptable). </span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Requires 4+ years experience documenting customer complaints(may be waived for applicant with Nursing License).</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Requires high level of attention to detail (for database entry and content review).</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Requires working knowledge of complaint database applications (SAP preferred)</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Requires working knowledge of document control systems (Bdocs preferred)</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Requires knowledge of 21 CFR 820 (Quality System Regulations), 21 CFR 803 (Medical Device Reporting) and Good Manufacturing Practices (GMP)</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Requires high level of computer proficiency. </span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Requires good communication skills (over the telephone, in person, and in writing)</span></li></ul><p style="margin: 0in 0in 0pt;"><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;"><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;"><strong><span style="font-family: 'Tahoma',sans-serif; font-size: 10pt;">Desired:</span></strong></span></span></p><ul><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Prefer 3+ years experience reviewing US Vigilance Reports (MDRs) within the medical device industry.</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Preferred: Internal Auditor certification (ASQ-CQA, or ISO 13485 lead auditor certification)</span></li><li><span style="font-size: 10.0pt; font-family: 'Tahoma',sans-serif;">Preferred: experience participating, and leading, CAPA investigations</span></li></ul> <img src="https://analytics.click2apply.net/v/1w86XquJnbjytAprUPeEa"> <p>PI112440477</p>

Categories

Posted: 2019-08-01 Expires: 2019-09-01

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior Quality Assurance Specialist, Complaints

Aesculap Inc.
Center Valley, PA 18034

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast