Hope your day is going well. I saw your profile online and tried reaching you a minute ago and left a voicemail. I hope you can call me back as soon as possible on 703-349-2825 so I can explain to you a bit more about the below role and our client. Please send me your updated resume. Looking forward to speaking to you.
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Job Description :
Position Title: Quality Engineer – USC or GC Only
No. of opening: 1
Duration: 4 Months
Location: Batesville , Indiana 47006
The QA Engineer, part of the QA team located in Batesville, IN, will work to provide the necessary data to make effective quality and business decisions, and will implement sound, data-driven quality and business solutions that emphasize quality system compliance.
Essential Duties and Responsibilities:
• The primary accountability of the QA Engineer is to support all initiatives to build product DHF, DMR
• Identify and mitigate quality risks
• Root cause investigations
• Process and Test System validation
• Develops and implements test methods and procedures for inspecting, testing and evaluating product and processes.
• Conduct part qualification (FAI, FMEA, GRR, Capability Study etc.) for both internal and external parts
• Conduct supplier audits and manage audit corrections meet deadlines
• Review and disposition product design and manufacturing process changes orders
• Other tasks as assigned
• BS in Engineering or closely related Bachelor's degree required
• 1-2 years of Quality/Regulatory experience is required
• Experience in the Medical Device industry is required
• Strong leadership skills, strong interpersonal skills, and the ability to deal effectively with system users are required.
• Knowledge of Quality Systems and Process Improvement is preferred.
• CQA, CQE or RAC preferred.
• Experience in Design Controls is desirable.
• Communication – displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels
• Flexibility and Adaptability – make effective decisions and maintain effectiveness under changing circumstances and priorities
• Teamwork, communication, positive attitude required to support the manufacturing environment
• Ability to read and analyze technical prints and drawings
• Problem Solving – able to perform root cause analysis and implement effective corrective actions
• Project Management – able to effectively manage and complete multiple projects simultaneously
• Computer Skills – Excellent computer skills including but not limited to Microsoft Office Suite
• Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations
Thanks and Regards,
Sr.Talent Acquisition Specialist
Osair Technologies LLC
Phone 703-349-2825, FAX : 732-289-6076
Suite # 16D, Clifton, Chapel road VA 12642.
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