Senior Quality Engineer en Leesburg, VA a Stryker Corporation

Fecha de publicación: 6/24/2019

Resumen de la oferta

Descripción del empleo

Who we want
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do

As a Senior Quality Engineer, you will design, validate and bring new products to market. You will specify precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluate the design's overall effectiveness, cost, reliability and safety. This person will design, develop, execute and evaluate fitness-for-use testing, product specifications and process validation plans; create and review material part specifications and bills of materials. You will collaborate with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability. This person will also utilize CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.

Responsibilities:

  • 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.

What you need

Basic Qualifications:

  • Bachelors Degree in Engineering.
  • Minimum 3 years’ experience in quality, manufacturing, new product development or engineering.

Preferred Qualifications:

  • Experience working in medical device or highly regulated industry desired.

Work From Home: No

Travel Percentage: Up to 25%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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