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Senior Staff Quality Engineer

3 months ago

Mahwah, United States Stryker Full time

Work Flexibility: Onsite

Stryker is hiring a Senior Staff Quality Engineer in Mahwah, New Jersey, to support Joint Replacement In this role, you will collaborate with various internal stakeholders to improve product quality, identify continuous improvement opportunities, and provide technical/compliance support.

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.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
  • Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
What you will do:
  • Build relationships with various divisions/business units the manufacturing facility builds product for.
  • Drive continuous improvement opportunities in the Quality Assurance area, including cost reduction opportunities. Previous Lean experience preferred.
  • Advocate for and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulation and standards.
  • Work closely with operations and the business functions to ensure quality performance of product and processes.
  • Provide oversight and approval of NC & CAPA, mentor in problem solving and root causing activities.
  • Coach, mentor, and assist in development of less experienced engineers.
  • Work collaboratively with operations & strategic partners, such as Manufacturing, Engineering, and Supply Planning to achieve strategic initiatives
  • Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
  • Ensure regulatory requirements are incorporated into projects and processes
  • Apply statistical methods to ensure reliability of the manufacturing process
  • Assist in the development, responsible for review & approval of process and equipment validation/qualification.
  • Responsible for initiation, management and support of Ship, Product Holds, potential product escapes
  • 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
What you need:

Required:
  • Bachelor of Engineering - Biomedical, Mechanical or related field required.
  • 6+ years of experience is required.
  • Experience in a regulated industry required.
Preferred:
  • Internal Quality Auditor Qualification preferred (ISO 13485, CFR 820 or comparable industry standard and regulatory requirements).
  • Experience in a highly regulatory environment desirable.
  • Knowledge of PFMEA, validation programs and SPC processes.
  • Understanding of manufacturing prints and tolerancing.


Travel Percentage: 10%

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.