Senior Quality Engineer
*Experience in Medical Device or Pharmaceutical.
**No 3rd party candidates please
The Senior Quality Engineer provides overall quality assurance leadership in the production of Medical Device products. Driving the operational quality culture at the manufacturing process level. Also conduct audits to good manufacturing practices, international organization for standardization and any other applicable standards.
You Will:
- 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 NCR/CAPA system indicators.
- Support all internal external audit or assessment to the site.
You Have:
- 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.