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Staff Engineer - Advanced Quality, Mechanical in Kalamazoo, MI at Stryker Corporation

Date Posted: 2/7/2019

Job Snapshot

  • Employee Type:
  • Location:
    Kalamazoo, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Provide support and direction for the implementation of quality systems associated with New Product Development projects for the Research, Development and Introduction of new Products, Processes and Technologies.

Has responsibility for quality engineering oversight, quality systems implementation including test and inspection plans and product reliability during product development, verification, validation and design transfer whilst ensuring compliance to FDA Quality System Regulations and ISO 13485.

Will work within the new product development team, with responsibilities including, but not limited to the following:

  • Guide NPI teams through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.
  • Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
  • Involved in developing, modifying, and executing design controls per company guidelines and procedures.
  • Provide input throughout the new product development process from a quality perspective
  • Lead risk management for project including risk analysis and development of sound mitigation strategies
  • Lead efforts for usability and human factors engineering
  • Collaborate with Design Engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
  • Support process and product validation programs for new product development
  • Educate NPI team on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
  • May perform supplier development activities surrounding PPAP
  • Develop and create procedures for incoming, in-process and final inspection of components and finished goods
  • May have involvement in continuous improvement projects for the organization
  • Knows and applies fundamental and some advanced concepts, practices and procedures of practical field of specialization.

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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