Address
Form of workJob Description
The Quality Engineer will be expected to use their training, experience, and good judgement to perform tasks assigned in the Quality DepartmentResponsibilities
- 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.
- 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
