Quality Engineer - Katalyst Healthcares & Life Sciences
Greater boston, MA 02284
About the Job
Roles & Responsibilities :
- You will help develop plans/strategies, and implementation of systems to ensure process performance.
- Support to manufacturing processes in a daily basis, by allocating enough inspection and investigation support.
- Work with operations and the departments to ensure quality performance of product and processes
- Lead and help develop the manufacturing processes for all products
- Resolve quality issues with suppliers and partner with internal customers.
- Approval of change management activities.
- Support manufacturing transfers to other plants/facilities, leading quality activities.
- Ensure efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans.
- Build and approve Process Validations (IQ, OQ, PQ, MSA/TMV)
- Identified quality issues are considered appropriated for immediate resolution and work to ensure that these are escalated to CAPA accordingly.
- Develop Process Failure Mode and Effect Analysis (pFMEA) to manage process risks.
- Perform root cause analysis investigations for Complaints, CAPA, Audit Findings and Non-Conformance Report NCRs and ensure on time completion and appropriate product disposition.
- Work with teams for problem solving activities.
- Report quality performance for assigned Value Stream.
- Participate as requires in Audits and Management Reviews
- Lead/ participate in quality systems and compliance improvements that results from all Audits, management Reviews and any other Client/CAPA system indicators.
- Support all internal external audit or assessment to the site.
Education & Experience :
- Bachelor's degree in Engineering or equivalent
- Minimum 5+ years work experience in quality, manufacturing, or engineering.
- Knowledge of 21 CFR 820, ISO 13485, ISO 14971 and EU MDR, and CE regulatory requirements
- Green Belt or Black Belt skills.
- Statistical Analysis ability.
- Perform Root Cause Analysis.
- A general understanding of Lean practices in manufacturing environment.
- Quality Certification.
- Proficient in using Microsoft Office Suite Software.
- Creative problem solving ability.
- Comfortable with complex technical analysis.
Source : Katalyst Healthcares & Life Sciences
