Why You'll Love This Job

POSITION OVERVIEW: The Quality Specialist II will be expected to use training, experience, and good judgement to perform tasks assigned in the Quality Department.

Responsibilities

Performs day-to-day Quality site checks on incoming, in-process and final products at the site
Ensure sites are following BioTouch Standard Operating Procedures and Work Instructions
Completes training as necessary at the site, documents training, and provides completed training records to global training coordinator
Assists in the CAPA process as assigned by Quality Manager
Assists in the Complaint process as assigned by Quality Manager
Assists in site specific projects as directed by the Quality Manager
Assists with updating Quality Metrics as assigned
May complete internal audits per the internal audit schedule and as assigned
May complete process walks of procedures with other departments
May assist in Supplier Management program
Managing the deviation process
Managing and closing Non-Conformances (NCRs)
Managing and actioning Customer Change Requests
COC/COA generation
Support new customer launches.
Additional responsibilities derived from organizational needs.

Skills & Qualifications

Basic knowledge of Microsoft Windows & Office
Knowledge and minimum 2 year experience working specifically in a regulated environment such as medical devices and experience with Quality Management Systems and Medical Device Regulations: CFR 820, ISO 13485
Ability to prioritize and shift priorities quickly as needed
Proficient verbal and written communication skills
Team-oriented with commitment to the success of the team and organizational goals to track and complete assignments
Ability to multi-task
Able to lift 40 lbs.

QUALIFICATIONS

College degree (Associates, Bachelor) preferred, or will consider HS graduate with 2 years’ experience in a Quality role.
Must possess ability to sit and/or stand for long periods of time.

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