We have Job Opportunity for QA Engineer at Bothell, WA with direct client
Duration: 4-6 months. Contract only
This is not Software QA/ Software testing role.
Need Candidates Authorized to work in US for any employer.
The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes.
The Product Quality Assurance Engineer:
• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
• Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the Quality Plan , any Risk Management activities, and of all design related activities during the product/system lifecycle
• Performs independent technical assessment on product quality performance and post-market product quality analysis
• Can Lead quality related problem solving and root cause analysis during design and manufacturing
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
• Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
• Produces and completes Quality Engineering documents under general supervision. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
• Responsible for performing timely, detailed quality engineering tasks like:
o Assessing product designs
o Reviewing test and other performance data
o Analyses of market feedback
o Completing or assisting with in root cause analysis and quality problem solving.
• Individual contributor interacting frequently with supervisors and peer groups.
• Works on issues where analysis of situation or data requires review of relevant factors. Exercises judgment within defined procedures and policies to determine appropriate action.
- 3+ year, preferably in medical device or other regulated industry.
- Required basic understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
If you have the above qualification and interested to apply please reply with your updated resume, contact no. and expected pay rate and I will contact you to discuss further.