Quality Engineer - Katalyst Healthcares & Life Sciences
Minneapolis, MN 55111
About the Job
Responsibilities and Requirements:
- A minimum with 5+ years of related experience Quality Management in Medical Device Industry.
- Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Pharmaceutical, procedures and guidelines, the duties and responsibilities for this position are.
- Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
- Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development.
- Non-Conformance Report (Client) process for Sterilmed business unit.
- Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
- Write, review and/or approve process and product validation protocols and reports, engineering change orders.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability, Design Controls, Design of Experiments.
- Technical problem solving, failure analysis, and root cause determination.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Generic Managerial Skills.
- Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking.
- English language.
- Must Have Technical/Functional Skills- experience Required.
- Knowledge of Medical procedure and corresponding Medical Equipment.
- Good experience in CAPA execution, CAPA write up.
- Good experience in Test Method Validation (TMV).
- Good experience in Process Validation.
- Knowledge of Medical Equipment manufacturing processes.
- Knowledge on Quality Management and its tools & techniques.
- Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations.
- Knowledge on NC, Audit processes.
- Knowledge in Statistic, Risk Management and Design control.
- Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills.
- Under limited supervision and in accordance with all applicable federal, state.
Source : Katalyst Healthcares & Life Sciences
