Senior Quality Engineer, Validation

Key Responsibilities

• Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports. 
• Participates in the development and execution of robust inspection and test methods for V&V feasibility and qualification projects and stand alone studies. 
• Leads or participates in the validation of corporate software packages ensuring adherence to industry requirements. 
• Use statistical techniques, as necessary, to properly design and execute V&V activities. 
• Prepare documentation and execute V&V activities utilizing a risk based approach (pFMEA, FMEA, etc.) and Good Engineering Practices (GEPs) ensuring compliance to medical device industry regulations. 
• Coordinate personnel training, protocol and process documentation/record retrieval, as necessary, supporting timely execution and closure of all corporate V&V activities.  
• Maintain corporate validation process auditing program ensuring timely completion of auditing activities. 
• Maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives in preparation for monthly update meetings. 
• Lead the identification, maintenance, development and enhancement of corporate systems, processes and standards. 
• Identify, analyze and correct internal and external manufacturing deviations and/or anomalies related to V&V activities ensuring optimization of production processes. 
• Successfully contribute to cross-functional project teams in all areas of device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, and investigation and process/test documentation. 
• Identify and communicate significant quality and compliance concerns to the Mgr. Validations, QA and associated project team leaders early in the V&V development phase. 
• Informs Regulatory Affairs of validation projects that may require further reporting/scrutiny (e.g. PMA devices). 
• Participate in the review and qualification of external supply chain V&V activities. 
• Take primary responsibility for company-wide validation related Corrective and Preventive Actions that may result from internal/external non-conformances, recalls and/or field actions. 
• Define and lead third party, customer and regulatory audits as they pertain to validations. 

Skills Knowledge and Expertise

• Bachelor’s Degree from an accredited institution required; Master’s Degree preferred  

• Advanced level of technical software proficiency 
• Excellent Quality System knowledge required 
• Strong time management and project management skills are necessary. 
• Experience writing IQ/OQ/PQ V&V protocols. 
• Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations.  
• General understanding of sterilization and related analytical testing is a plus. 
  Must be able to work independently and in a team environment.  

• Statistical expertise in areas such as process capability, process assurance and sampling 
• Expertise in Microsoft Office products 
• Ability to work effectively in a team environment 
• ASQ Certifications preferred 
• Advanced level of technical software proficiency 
• Working knowledge of statistical analysis and sampling plans. 
• Excellent communication (written and verbal) skills. 
• Excellent organization skills. 

Reports To