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Quality Specialist II

3 months ago

Midland, United States BioTouch Full time
Job DescriptionJob DescriptionThe Quality Specialist will be expected to use training, experience, and good judgement to perform tasks assigned in the Quality Department.   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.
Required Skills
  • 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.