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Senior Engineer, Post-Market Quality in Tempe, AZ at Stryker Corporation

发布日期: 5/22/2019

职位快速浏览

  • 员工类型:
    Full-Time
  • 位置:
    Tempe, AZ
  • 职位类型:
  • 经验:
    Not Specified
  • 发布日期:
    5/22/2019
  • Job ID:
    R414629

职位描述

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.

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

What you will do

The Senior Post-Market Quality Engineer is responsible for developing innovative, cost-effective solutions to improve released product quality, support continuous improvements and drive customer engagement. The Senior Post-Market Quality Engineer will drive process initiatives that ensures compliance with customer requirements, regulatory agencies, government regulations and engineering specifications while adhering to regulatory requirements and quality standards

Responsibilities:

  • Project facilitation and/or team member engagement; oversee risk management and regulatory requirements related to sustainment of new or existing products and services, including (but not limited to) line extensions, design changes and process/product/quality improvements.
  • Troubleshoot product quality related issues, determine root cause failure, and implement corrective actions.
  • Plans, designs and /or implements innovative, cost-effective solutions to improve released product quality and support continuous improvements.
  • Represent Division Quality on Continuous Process Improvement Teams.
  • Contribute to department metrics related to quality, customer experience, innovation, people development, and financial performance.
  • Ability to effectively interact within a team environment and with other departments such as R&D, Operations, Regulatory Affairs, Mfg. Engineering, Customer Service, Marketing, Sales, as well as external customers and suppliers.
  • Advanced understanding of statistical analysis principles as they relate to data analysis and testing reports.
  • Provide analysis of data in support of quality and process improvements.
  • Uses problem analysis to proactively identify quality process solutions.
  • Support quality product issues in the field through customer interactions and/or field visits to solve product quality issues and /or answer general product questions.
  • Partner with Manufacturing and internal business groups to develop recommendations and execute corrective actions.
  • Optimize processes using engineering methods for continuous process improvement. Identify opportunities for improvement to reduce risk and increase product quality.
  • Supports post-market investigations through quality systems such as PMHRA, NC/CAPA, and PFA.
  • Broad knowledge of applicable regulations and standards (e.g. QSR, ISO 13485).
  • Plans, leads, monitors, and/or controls progress of difficult projects to ensure sound application of engineering principles are used, and design intent is being achieved.
  • Analyzes, designs, and/or improves difficult manufacturing procedures and engineering systems for post-market medical devices.
  • Plans, performs, and reviews difficult post-market engineering risk analyses to manage technical difficulties.
  • Provides leadership in the post-market product development process by identifying standard test methods.
  • Plans and leads departmental initiatives.
  • Demonstrates technical leadership as a departmental resource.
  • Provides leadership and mentoring to more junior staff.
  • May work with verbal and/or written instructions.
  • May train others in quality assurance / GMP related topics.
  • May direct and/or evaluate the activities of one or more Post-Market Quality Engineers.

What you need

Basic Qualifications:

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

Preferred Qualifications:

  • Bachelor's Degree (B.S.) in Electrical, Mechanical, or Biomedical Engineering or related science field.
  • 5+ years practical engineering experience (medical device company preferred).
  • Six Sigma Green Belt or ASQ CQE 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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