Staff Quality Engineer

Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards

Position Requirements:

• 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 Operations and the business functions to ensure quality performance of product and processes.
• Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
• Lead and participate in the development of the internal Lab focusing on system performance and continuous improvement opportunities.
• Liaise with external Suppliers including external contract Lab ensuring best in class service and maintaining high quality performance.
• Review and approval of change management activities.
• Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
• Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
• Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
• Proficiency in statistical methods and application.
• Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
• Assist in the development, responsible for review & approval of process and equipment validation/qualification.
• Support manufacturing transfers to other plants/facilities, leading quality activities.
• Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
• Coach and mentor others in quality topics and activities.

Qualification/Skills Required :

Bachelor degree in Science, Engineering or equivalent/ related subject and 4 or more years of work experience in a quality discipline.

Previous experience in a Lab based environment desirable.

Proficient in understanding of Med Device manufacturing processes desirable.

Familiarity with ISO 13485, GDP, GMP desirable.

Lean Six Sigma training a distinct advantage.

Excellent communication skills and attention to detail.

Have a good understanding of Quality and Lab practices & methods.

High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.

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.

Working 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.

Manages change well 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 functionally