Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & 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.
Ability 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.
Ability 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.
Ability to understand and follow complex written procedures is required.
Ability to function in a team environment and deliver on team objectives is required.
Ability to make decisions and solve problems while exhibiting situational judgement.
Requirements:
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.
Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc).