Why You’ll Love This Job
The Quality Specialist III will be expected to use training, experience, and good judgement to perform tasks assigned in the Quality Department.
Job Duties and Responsibilities
- Leads the CAPA program at BioTouch (Global) including leading CAPA Review Board, and CAPA & Continuous Improvement Projects
- Leads the Complaint program at BioTouch including tracking, trending, and updating associated metrics
- Completes Regulatory Risk Assessments related to Complaints
- Leads the Supplier Management program
- Assists with updating Quality Metrics as assigned
- Completes internal audits per the internal audit schedule and as assigned
- Conducts process walks of procedures with other departments
- Provide back-up coverage for other quality positions as needed.
- Other duties as assigned.
- Basic knowledge of Microsoft Windows & Office
- Thorough knowledge and minimum 3 years experience working 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
- College degree (Associate, Bachelor, or equivalent experience) in sciences, quality management, biology, or similar.
- Must possess ability to sit and/or stand for long periods of time.
Type: Full Time (Hourly)
Job ID: 116581