Sr. QA Engineer - Field Support - Austin, Texas United States - 33807



JOB DESCRIPTION

Job #: 33807
Title: Sr. QA Engineer - Field Support
Job Location: Austin, Texas - United States
Employment Type:
Salary: $95,000.00 - $115,000.00 - US Dollars - Yearly
Other Compensation: 15% bonus, solid benefits plan
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


Great opportunity for an engineer with a quality background to really dig in and investiate details behind field failures of customer products (medical device company with 2000 SKUs). This is a big, recently realized critical need of the company and this newly formed team has a lot of visibility. 

JOB DESCRIPTION

The Senior QA Engineer – Field Support will be responsible for:

 

A Brief Overview
 

Senior QA Engineer – Field Support is responsible for supporting and leading Field Quality investigation efforts. This includes data analysis and root-cause investigations, RMA investigations, development of detail Risk profiles for issues, reviewing and collating field quality data to pro-actively identify potential field issues and initiating and supporting recall activities.
 

What you will do
 

  • Provides customer complaint technical investigation, analysis, escalation and closure
  • Ensures proper review, classification, investigation and closure of customer complaints.
  • Works in the RMA process including investigations and resolutions, identification of removal and corrections which require escalation, RMA metrics development, analysis and action determination
  • From RMA and Complaints initiates recall investigations, complaint investigations and recall investigations. Oversees the approval of RMAs.
  • Manages recall management. Includes tracking and closure. Oversees CAN deployment and management
  • Collects and analyzes, presents and initiates appropriate action for all field quality data
  • Coordinates and participates on required internal investigations interfacing with internal groups (QA, Operations, Research and Development, RA, Technical Support and Field Support)
  • Prepares presentations for EMR, IQR an RQR providing Field Quality Performance metrics.
  • Participates in Audits – internal and external, as SME or escort. Represents the organization in external audits for Field Quality, RMA, Removal and Corrections and Complaint investigation status.
  • Understands and applies QMS processes for RMA, Risk Analysis, Complaint Investigations and ensures alignment to necessary governing regulations both domestic and international.
  • Responsible for all aspects of regulatory compliance and regulations

 

QUALIFICATIONS

Education Qualifications
 

  • Bachelor's Degree Bachelor degree required, in a life science/engineering discipline preferred and minimum 5 years’ work experience in a regulated / medical device industry required

Experience Qualifications
 

  • 1+ Years Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 14971, CFR 820 and CFR 806 preferred
  • 2+ Years Experience in a complex manufacturing or product development role preferred
  • 3+ Years Ability to provide leadership to others in the organization through influence, innovative practices and coaching skills to foster a corporate culture of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance. preferred
  • 2+ Years Possesses a strong scientific and technical background, sufficient to establish creditability with senior management as well as the manufacturing and product development teams. preferred
  • 2+ Years Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues. preferred
  • 2+ Years Hands-on ability to sort through technical complexities and work in a flexible changing environment. preferred

Training and Skills
 

  • Excellent interpersonal, verbal and written communication skills
  • Thorough knowledge of standards and regulations (cGMP, ISO 13485)
  • Certification in a quality discipline preferred, such as CQM, CQA
  • Highly organized with proven time management and prioritization skills
  • Ability to work independently and with minimal supervision
  • High degree of problem solving, attention to detail, and analytical skills.
  • Experience working independently in a fast-paced environment with rapidly changing priorities

Travel Requirements
 

  • 10% travel may be required

Education:
University - Bachelor's Degree/3-4 Year Degree

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