Senior Quality Engineer in Cestas, France

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Senior Quality Engineer – temporary assignment

Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions with a focus on cost reduction initiatives. Advocate and lead the execution of inspection optimization activities, keeping a high quality performance within the business and for our customers. Ensure compliance to regulation and standards.

You will work within the quality operations team, under moderate supervision and mentoring, with a daily business responsibility for quality related activities (internal and supplier), including, but not limited to the following:

• Work closely with operations and the business functions to ensure quality performance of product and processes

• Launch Inspection Optimization activities

• Own, oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities

• Disposition non-conforming product within MRB, issuing NC’s as appropriate

• Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required. Lead the solving of supplier quality issues impacting daily operations

• Lead and participate in the development and improvement of the manufacturing processes for existing products

• Lead the deployment of cost reduction initiatives

• Support and collaborate with EUMDR team for the management of non conformities

• Participates and leads the creation and/or review of new or modified procedures

• Initiate KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary

• Support execution and analysis of manufacturing related complaints and product field actions (PFA)

• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation

• Develop and provide input for risk management by identifying opportunities and weaknesses

• Support the creation and maintenance of inspection methods and sampling

• Proficiency in statistical methods and application

• Assist in the development, responsible for review and approval of process and equipment validation/qualification and MSA of internal processes

• Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes

• Support execution and analysis of QATs

• Support First Article Inspections

What you need:

• Engineering studies with 2 or more years of experience in biomedical or regulated environment

• Proven previous experience in industrial quality environment (production, engineering), experience in supplier management is a plus

• Systems: experience in quality tools, NC/CAPA management as well as project management, Qualification/ Validation process knowledge

• Good communication skills, capable of influencing without authority, good organizational skills, leadership, critical thinking, high responsiveness

• Languages fluent in French & English

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.