Sr. QA Engineer - Field Support
|Austin, Texas - United States
$95,000.00 - $115,000.00 - US Dollars - Yearly
|15% bonus, solid benefits plan
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.
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
- 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
- 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
- 10% travel may be required
University - Bachelor's Degree/3-4 Year Degree