Why You’ll Love This Job
The Quality Engineer will be expected to use their training, experience, and good judgement to perform tasks assigned in the Quality Department
Job Duties and Responsibilities
- Leads the Validation program 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- Lead activities including authoring and ensuring IQ/OQ/PQs are completed
- Participates in updates to Risk Management, Assists in pFMEA updates and evaluations.
- Leads the CAPA program at BioTouch (Global) including leading CAPA Review Board, and CAPA & Continuous Improvement Projects
- Leads the Supplier Management program: Surveys, Annual Reviews, Metrics, Audits, SCARs
- 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
- 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: 142780