Sr. Quality Engineer (Fda Regulated)

Senior Quality Engineer

*Ideal experience in Medical Device or Pharmaceutical.

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:

• Participate as requires in Audits and Management Reviews
• Develop Process Failure Mode and Effect Analysis (pFMEA) to manage process risks.
• Report quality performance for assigned Value Stream.
• Build and approve Process Validations (IQ, OQ, PQ, MSA/TMV)
• Support all internal external audit or assessment to the site.
• Identified quality issues are considered appropriated for immediate resolution and work to ensure that these are escalated to CAPA accordingly.
• Work with operations and the departments to ensure quality performance of product and processes
• Work with teams for problem solving activities.
• Lead and help develop the manufacturing processes for all products
• Support manufacturing transfers to other plants/facilities, leading quality activities.
• Lead/ participate in quality systems and compliance improvements that results from all Audits, management Reviews and any other NCR/CAPA system indicators.
• Approval of change management activities.
• 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.
• Ensure efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans.
• Resolve quality issues with suppliers and partner with internal customers.
• Perform root cause analysis investigations for Complaints, CAPA, Audit Findings and Non-Conformance Report NCRs and ensure on time completion and appropriate product disposition.

You Have:

• Quality Certification.
• A general understanding of Lean practices in manufacturing environment.
• Bachelor's degree in Engineering or equivalent
• Minimum 5+ years work experience in quality, manufacturing, or engineering.
• Creative problem solving ability.
• Statistical Analysis ability.
• Proficient in using Microsoft Office Suite Software.
• Comfortable with complex technical analysis.
• Perform Root Cause Analysis.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971 and EU MDR, and CE regulatory requirements
• Green Belt or Black Belt skills.