Senior Supplier Quality Engineer

This is a 12 month contract role with full Stryker benefits.

Provide Supplier 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.

Responsibilities

• 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 and improvement of the manufacturing processes for existing and new products.
• Analysis and review of concession requests.
• Review and approval of change management activities.
• Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
• Support execution and analysis of QATs.
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
• 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.

Qualifications

• Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline, or
• Masters of Science, Engineering or related subject with 0 years of experience
• Previous experience in a regulated environment desirable.
• CQE or equivalent course work / experience desirable
• Proficient in understanding of Med Device manufacturing processes desirable.
• Familiarity with ISO 13485, GDP, GMP desirable.