US-MN-BrooklynPark: QA Engineer
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please visit http://sqa.fyicenter.com
Prepare and review Characterization / Qualification / Validation Test Plans and Reports for assigned projects and product lines. Provide technical support to resolve any testing related issues. Assure the resolution of all issues raised and ensure highest product quality.
• Participates in the development projects to represent QA function. Ensures that all testing meets the requirements.
• Manages assigned product lines and mfg processes to ensure highest product quality.
• Leads and/or participates in corrective/preventive action teams in resolving production and customer issues. Dispositions any materials / components that are rejected for non-conformance with effective corrective actions.
• Leads or participates in audit/assessment of the manufacturing operations including any supplier audits.
• Review changes to products in production for reliability impact to aid in the correction of process, design or materials problems. Leads process improvements and process streamlining.
• Evaluate field performance of assigned products by reviewing field data, supporting technicians to evaluate unusual returns and supporting Technical Services and Consumer Affairs in responding to customer.
• Provides statistical support by leading creation of manufacturing related metrics for improvement purposes.
• Support Supplier Quality by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met.
• Support Regulatory Affairs by providing reliability input in the evaluation of MDRs and submissions of requests for approval to the FDA.
• Investigates and evaluates product field problems. This includes preparing Health Hazard Analysis and working with Marketing, Product Development and Regulatory on field action plans.
• BS in Engineering or related field
• 7+ years working in a Quality organization in the medical device industry
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Team SQAFYI - Software QA Resource FYI