Job summary
This position leads validation and quality engineering activities for internally manufactured productsResponsible for developing and maintaining procedures and policies in accordance with regulatory requirementsOwner of the process validation system
Job seniority: mid-to-senior level
Responsibilities
• Develop validation plans, protocols and reports for assembly and packaging processes• Develop and manage validation standard operating procedures in compliance with regulatory requirements• Develop and maintain validation protocol and report templates• Develop test method validation (TMV) protocols and reports for automated and manual inspection methods• Provide quality engineering support for semi-manual and automated equipment development• Review equipment URS, FAT/SAT against quality requirements• Support design transfer of internal manufacturing processes• Perform statistical analysis of validation and production data• Supports manufacturing process development & qualification for product changes• Leads CAPA/NCR/SCAR investigations and reports
Requirements
• Bachelor level degree in Engineering (Mechanical or Biomedical) or related Science• 5-7 years relevant experience within medical device industry or related function• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance• Good statistical data analysis skills (Minitab)• Lead auditor certification preferred• Design for Six Sigma and Critical to Quality training and experience a plus• Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus• Ability to manage multiple projects• Excellent verbal and written skills• Able to work independently, as well as in a team environment
Key Skills Needed
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance• Good statistical data analysis skills (Minitab)• Lead auditor certification preferred• Design for Six Sigma and Critical to Quality training and experience a plus• Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus• Ability to manage multiple projects• Excellent verbal and written skills• Able to work independently, as well as in a team environment• Customer focused and service oriented• Ability to educate stakeholders, customers and management• Ability to interface with internal customers, 3rd-party partners, Health care providers (HCPs) and regulatory agencies• Experienced working with cross-functional teams• Excellent communication skills (verbal and written)• Experienced with participation in audits• ASQ certification a plus
