Katalyst Healthcares and Life Sciences
Responsibilities:
- 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.
- Can Lead and Manage Team at onsite/offshore.
- Must Discuss with client for project plan and its implementation.
- bility to understand the project scope of impacted products and identify the affected parts and documents.
- Build the ECO strategy and work with affected cross functional teams• Update the affected CAD drawing files and product documents.
- Identify the potential risks/issues and accordingly plan for any changes required• Prepare Characterization Reports.
- Support Risk management files review/update (DFMEA, PFMEA).
- Develop and establish effective quality control and associated risk management plans.
- Support closure for CAPA/NC.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
- Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
- Work in a cross-functional team environment, working with engineering, manufacturing, marketing and suppliers.
- Creation of ECOs to upload documentation changes to PLM system (Windchill).
- Know & follow policies & procedures related to work activities performed in area of responsibility.
- Complete training in area of responsibility within allowed time-period and periodic retraining in areas.
- Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
- bility to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
- Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
- bility to understand and follow complex written procedures is required.
- bility to function in a team environment and deliver on team objectives is required.
- bility to make decisions and solve problems while exhibiting situational judgement.
- Design Quality Engineer 4+ years of experience & demonstrated proficiency in Design Quality & providing ongoing technical support is preferred with evidence of continued self-development Work experience in the Medical Device industry.
- GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs.
- Strong creative, analytical and problem-solving skills.
- Proficient at interpreting data and putting that data into a report.
- Proficient at statistical analysis.
- Experience in EU MDR or other regulatory related projects.
- Verification and Validation.
- CAD Support (Preferred Auto CAD and SolidWorks).
- Experience in creating PFMEAs & Writing reports.
- Experience in PMS (Post Market Surveillance).
- Experience in PLM Tool (Windchill).
- Process experience, ability to observe and understand manufacturing processes.
- Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred.
- Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software.
- bility to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc).