Job description

One of our clients is looking for a talented and highly motivated Medical Device Quality Engineer 3. Please send your resume if you want to pursue this opportunity and authorize Infosoft to represent you for this position.

Here are the job position details for your review:

Job Title: Medical Device Quality Engineer 3
Pay Rate: $40 to 45/Hr
Duration: 6 Months
Location: Austin, TX

This position is for the Healthcare Diagnostics division.

Medical Device Quality Engineer 3 will join the Quality Engineering team, responsible for providing hands-on and strategic support in overseeing microsphere manufacturing projects for medical device/diagnostic products. This individual will be responsible for authoring, reviewing, approving, and modifying quality and manufacturing documentation, specifically for the equipment qualification, and equipment/process/test method validation protocols. This individual will also be drafting and updating PFMEA documentation and working on CAPA and nonconformance issues.

Required Experience:

• 5+ years working with FDA-regulated medical device quality systems
• Minimum BS in engineering or a similar scientific discipline
• Med Device Class II and or III device experience (ISO 13485, CFR 820)
• Quality and Manufacturing Document Authoring, modification, and review
• Process Validation
• Equipment Qualification
• IQ/OQ/PQ
• SAP experience
• Document drafting, review, and approval
• Validation/Qualification protocol/report drafting, review, approval
• Risk management w/ in the med device industry
• PFMEA drafting/updating
• CAPA and root cause analysis experience
• Experience with Engineering Change Procedures

Preferred Experience:

• Test method experience
• Experience in environments with chemistry and/or polymer manufacturing

Additional Skills / Knowledge

• Computer and technology skills
• MS Office Suite
• Adobe
• Document management systems

Job Types: Full-time, Contract

Salary: $40.00 - $45.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Austin, TX 78717: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• please provide your email address

Education:

• Bachelor's (Required)

Experience:

• CAPA and root causes analysis: 3 years (Required)
• test method validation protocols: 3 years (Required)
• manufacturing documentation: 3 years (Required)
• Medical device: 3 years (Required)

Work Location: One location

Speak with the employer
+91 7355185057

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