Quality Engineer

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.

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 / deputise 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.
• Proficiently step in for management in temporary absence, periodic review boards, business meetings etc on a regular basis.

• 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.
• Builds strong relationships by fostering open communications, respect and trust.
• Strong team player and acts with a customer service/stakeholder focused approach.
• Presents as a change agent and adopts a continuous improvement orientation to the role.
• Excellent English (both oral and written).