Senior Quality Engineer, NPI en Leesburg, VA a Stryker Corporation

Fecha de publicación: 2/16/2020

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, New Product Introduction (NPI), you will provide quality engineering support and direction in quality assurance, control and preventative activities in the development and introduction of new Products, Processes and Technologies, with focus on quality systems development, risk management, test & inspection strategies and product reliability. Advocates and leads the execution of quality activities in process development, verification, validation, design transfer and post market release phases whilst ensuring compliance to regulation and standards. Knows and applies the fundamental and advanced concepts, practices and procedures of NPI process quality specialization.

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:
  • Initiate and build productive and collaborative internal/external professional relationships across Design Divisions & GQO functions associated with design transfer activities. Encourage, inspire, and influence others, creating a positive impact on the team.
  • Communicate effectively with all Customers, Stakeholders and project teams in delivering on quality, transfer and NPI project goals.
  • As a key member of NPI project teams, be accountable for implementing quality systems while achieving product/process performance, quality objectives, project planning and effective execution, as well as communicating program status and escalating issues when appropriate.
  • Ensure that customer and regulatory requirements are incorporated into process specifications and ensure these requirements have been met before product is released to market.
  • 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.
  • Ensure Risk Management documents are generated, applied to the process to minimize risk to patient or user harm. Ensure all Risk Management outputs comply with ISO14971 for use in Regulatory Submissions.
  • Support process development, process characterization and capturing process knowledge to facilitate subsequent process validation and monitoring activities ensuring ongoing product compliance.
  • Has the authority to order the cessation of all activities in relation to process validation and new product introduction. In addition, has the authority to order recommencement of these activities provided he/she is satisfied that all issues affecting product safety and efficacy have been addressed. Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
  • Support the development and implementation of process improvements, inspection strategies and plans for associated NPI projects. Proficient in and makes continuous strides towards optimization of inspection methods and sampling. Leads / Support First Article Inspections.
  • Minimize inspection costs while maintaining safety, integrity and reliability of the product.
  • Support supplier quality with vendors during NPI phase in developing quality systems and resolving any quality issues in relation to audits findings, technical specifications, process validation, problem solving, sampling plans development and inspection techniques.
  • High proficiency in statistical methods and application. Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
  • Subject Matter Expert in Design Transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise. Support audit preparation strategy and execution.
  • Lead and plan Design Transfer file activities from initiation to close out.
  • Support audit preparation strategy and execution. Participate in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
  • For new products, ensure the efficient and timely transfer of Quality systems knowledge to Ops Quality and coordinate the training of Quality Engineers and related personnel on new quality systems and equipment as necessary. 
  • Establish and report new products quality metrics and Monitor during Post-Market launch for prescribed period.
  • Perform QMS Review and Approval of all NPI process deliverables, including process changes.
  • Ensure all appropriate documentation is in place prior to production launch.     
  • Oversight and approval of NC & CAPA related to new products, activist and mentor in problem solving and root causing activities.
  • Analysis and review of concession requests.
  • Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.

What you need:

Basic Qualifications:

  • Bachelors Degree
  • Minimum 3 years experience in NPD, quality, manufacturing, operations or working in a highly regulated environment

Preferred Qualifications:

  • Bachelor’s Degree in Engineering discipline preferred; Biomedical, Process, or Mechanical Engineering recommended.
  • Previous experience in a regulated environment within an R&D or manufacturing environment.
  • CQE or equivalent course work / experience desirable
  • Proficient in understanding of Med Device manufacturing processes desirable.
  • Familiarity with ISO 13485, QSR, GDP, GMP desirable.
  • Lean Six Sigma training a distinct advantage.
  • Working knowledge of Process Validation and Computer System validation
  • Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment.
  • Ability to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerance.
  • Experience in executing complex problem solving techniques related to design/technical issues. Good instincts and sound judgment for mechanical and structural design.
  • Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.  Open minded- able to recognize good ideas.
  • Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
  • Excellent English (both oral and written)
  • Ability to be the voice of Quality when dealing cross functionally

Work From Home: Not available

Travel Percentage: 20%

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.

Únase a nuestra red de talentos

Si se une a nuestra red de talentos, mejorará el proceso de búsqueda y solicitud de empleo. Tanto si desea solicitar un trabajo como si solo quiere dejarnos sus datos, deseamos mantener el contacto con usted.

Únase a nuestro equipo