Provide quality oversight of device assembly and packaging operations
Serve as on-site quality oversight for medical device and combination product operations requiring above-site support
Accountable for coordinating Device Quality and Regulatory triage and root cause investigation of deviations impacting device assembly and packaging operations
Provides oversight of CAPA for device assembly and packaging operations including CAPA approval, performance of effectiveness checks and CAPA metric monitoring
Builds strong partnerships with site Operations, Packaging Technical Operations, Validation, Global DQ&R, and other functions to ensure seamless execution of device quality activities
Represents Device Quality and Regulatory for device related internal and external audits

Requirements

Bachelor's degree in relevant discipline
5 years of relevant experience in quality assurance in a medical device or medical device combination product manufacturing organization
Strong technical and innovative problem solving skills
Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
Demonstrated ability to partner and collaborate with cross-functional personnel and experience operating in a matrix organization
Familiarity with device design verification and design control aspects
Strong knowledge of device assembly and packaging operations

Benefits

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

quality assuranceCAPAdevice assemblypackaging operationsroot cause investigationdesign verificationdesign control

Soft Skills

problem solvingcommunicationinterpersonal skillscollaborationcreativity

Certifications

Bachelor's degree