What are the responsibilities and job description for the Design Quality Engineer position at 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.
Requirements :
