Why You’ll Love This Job
The Quality Specialist 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 site Non-Conformances and investigations
- Completes Complaints and investigations as assigned
- Performs validations at BioTouch (Global)- ensures all current process/equipment meet BioTouch Validation program requirements & remediate as necessary
- Ensure all new processes and equipment follow BioTouch Validation Program- complete IQ/OQ/PQs
- Participates in updates to Risk Management, Assists in pFMEA updates and evaluations
- Leads site Non-Conformances and investigations
- Completes Complaints and investigations as assigned
- Assists with updating Quality Metrics as assigned
- Completes assigned internal audits per the internal audit schedule and as assigned
- Conducts process walks of procedures with other departments
- Ability to lead projects and manage tasks as assigned with Global projects
- Provide back-up coverage for other quality positions as needed.
- Other duties as assigned.
Qualifications
- Thorough knowledge and minimum 5 years experience working specifically in a Validation Program, CAPA management, and Supplier Management in a regulated environment such as medical devices and experience with Quality Management Systems and Medical Device Regulations: CFR 820, ISO 13485
- Project Management knowledge and skills
- 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
- Basic knowledge of Microsoft Windows & Office
- Ability to use eQMS, WMS systems
- Ability to multi-task
QUALIFICATIONS
- College degree (Bachelor, may consider equivalent experience) in sciences, Biomedical Engineering, quality management, biology, or similar.
- Must have knowledge and minimum 5 years experience working in a Validation Program and Quality Systems in a regulated environment such as medical devices or pharmaceuticals, and experience with Quality Management Systems and Medical Device Regulations: CFR 820, ISO 13485
Must possess ability to sit and/or stand for long periods of time.
Type: Full Time (Hourly)
Job ID: 136076