Job opportunity | Quality Engineer | Duluth, GA

My name is Irfan Ali from Nextgen Technologies. I found your profile in our database while looking for the Quality Engineer our client. I was impressed by your background and decided to drop you a note with below job description. Any referrals would also be highly appreciated.

Position Description: Nextgen Technologies has an exciting Contract opportunity for a Quality Engineer with our client.

Here is the description!

Quality Engineer

John Creek, Duluth, GA

Duration: 24 months

Description:

The Associate Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.

Job Duties:

Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.

Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness

Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.

Performs hands-on troubleshooting of customer-returned devices and manufacturing nonconformities and completes associated technical documentation

Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization

Proficient in project management, data analysis, root cause analysis, communication, and risk determination

Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Top 3 must-have skill sets :

Cross-functional communication skills (will be working with all teams), Critical thinking (allows for quick on-the-spot thinking and ways to navigate unfamiliar issues), prioritization (this position will pull you in all directions so knowing what is important is key)

Years of experience required: 0-2 years of experience in Medical Device /Pharmaceutical regulated industry.

Specific education requirements: Minimum - Bachelor's Degree with Engineering or Physical Science Coursework,

Preferred - Bachelor's or master's degree in engineering with 0-3 years' experience in Medical Device /Pharmaceutical regulated industry. ASQ Certification (e .g. CQA, CQE, CQM )

If you're interested, I'd be happy to share additional details and discuss the opportunity. If you know someone who may be a good fit, I would sincerely appreciate your referral.

I look forward to hearing from you.

Thanks & Regards,

Irfan Ali | Talent Acquisition

Email View email address on us.fitly.work

1735 North 1st Street #102, San Jose, CA 95112, USA