Role description

Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following: 

• Work closely with business functions assess, provide oversight and direction on quality performance of product and processes.  
• Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.  
• Coach and mentor the quality team and others business functions in quality topics and activities, with several topics at expert level.  
• Leads / Manages quality initiatives / projects at local & global level.  
• Recognized process owner in areas of expertise. Expertise across multiple areas from the following, problem solving, risk, concession & change management, lean, six sigma, CAPA, statistics, validation, inspection processes & sampling etc.  
• Input into local, global & corporate processes, a representative on review & discussion boards and teams for expert & valued input.  
• Provides input / assessment and justification at expert level during concession / change management and quality issues. Review and approval of same driving strong review.  
• Interpret KPI trends, take action as necessary, driving a continuous improvement process.  
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.  
• Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Oversight/deputize for audit management, logistics and preparation as required.  
• Aids in the development of validation strategies, certified in multiple disciplines of validation to approval level.  
• Support/ Leads manufacturing transfers to other plants/facilities, leading quality activities.  
• Responsible for initiation, management and support of ship, product Holds, potential product escapes.  
• Steps in proficiently for management in temporary absence, periodic review boards, business meetings etc on a regular basis 

Education and experience:

• Masters of Science, Engineering or related subject with 6 years of
• experience in a quality discipline.
• Previous experience in a regulated environment required. 
• Proficient in understanding of Med Device manufacturing processes, ISO 13485, GMP.
• Lean / Six Sigma training a distinct advantage.
• Excellent communication skills and attention to detail.
• Have a good understanding of engineering and quality practices & methods.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages. 
• Exhibits strong leadership and mentoring behaviors. 
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment. 
• Must be willing to work as part of a multi-site team, with some travel required. 
• High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs. 
• Highly developed problem solving and strong analytical skills. 
• Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
• Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes. 
• Presents as a change agent and adopts a continuous improvement orientation to the role.
• Excellent English (both oral and written).
• Ability to be the voice of Quality when dealing cross fun.