We design and manufacture the most advanced electromechanical systems for the Medical Device & Pharmaceutical Industries. These systems are used for R&D to clinical to GMP production.

SUMMARY:

• As the Quality Engineer you will be responsible for validation activities related to product development and commercialization our systems. This role requires experience related to validating medical devices. Leading process improvement projects which utilize Quality Engineering methods such as Six Sigma, Lean, Kaizen, and/or have experience performing Quality Assurance functions such as Investigations, CAPA, Root Cause Analysis, and Change Control. This role requires effective cross functional collaboration, strong oral communication skills, and proven technical writing ability. This position reports to the Head of Quality.

MUST HAVES:

• BioTech, Medical Device, or Pharmaceutical Experience
• Experience creating Validation Procedures on Process and Product
• QMS experience
• Lean Experience

DUTIES & RESPONSIBILITIES:

• Work with product development Engineers to define Quality requirements, develop, approve, and execute protocols for testing, design verification and validation of various components and functions of bioreactor systems.
• Development, testing, verification/validation of electromechanical bioreactor control units, single use bioreactor vessels, bioreactor system controls and related software.
• Create and manage procedures which govern validation program, validation master plan, and related forms, templates, and training.
• Provide Quality requirements, procedures, and oversight for validation of manufacturing process, facility and equipment.
• Perform change assessments and write reports for impact of changes to validated state; may be assigned as Quality contact for Change Control records.
• Lead process or product improvement projects which require Quality Engineering methods or support Quality Assurance
• Lead or support development and implementation of manufacturing process controls or process monitoring
• Lead investigations, root cause analysis, and troubleshooting related to product or validated processl

REQUIRED EXPERIENCE:

• Bachelors in Engineering or Science
• 3+years in a Quality Validation Related Opportuntiy.
• 3+ years of Quality Management System preferably in a medical device or related industry.
• 3+ years of Six Sigma/DMAIC methodology (or equivalent) such as value stream mapping, FMEA, Kaizen, SIPOC analysis, root cause analysis, fault tree analysis, risk analysis and pareto charting OR 3 years of experience in a Quality Assurance related role performing Investigations, CAPA, Change Control, or product quality evaluations in a regulated environment.