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Stryker Jobs – Senior Quality Engineer

Stryker

Job Description:

As a Senior Quality Engineer, you will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Additionally, you will support supplier quality issues impacting daily operations; advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers; ensure compliance to regulation and standards. This role will also focus on new product launch and sustainment support for Integrated Manufacturing business unit in Kalamazoo, MI.

Job Responsibilities:

  • Support execution and analysis of manufacturing related complaints and product field actions.
  • Disposition non-conforming product within MRB, issuing NC’s as appropriate.
  • Support the development and review of process and equipment validation/qualification and MSA of internal processes.
  • Engage in the development and improvement of the internal manufacturing processes for existing products.
  • Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
  • Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.
  • Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
  • Participates and may lead in the creation and/or review of new or modified procedures.
  • Applies statistical methods of analysis and process control to current operations.
  • Performs critical assessment of internal and supplier proposed change management activities.
  • Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
  • Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.
  • Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
  • Collaborates with Divisional QA, cross-functional and suppliers’ teams to address top quality issues.
  • Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
  • Performs PPAP activities for supplier changes
  • Support the creation and maintenance of inspection methods and sampling.
  • Work closely with operations and the business functions to ensure quality performance of product and processes.
  • Engage and interface in internal and external audits providing subject matter expertise
  • Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.
  • Support improvement projects or new product launch activities by working with cross-functional team
  • Own identified internal and supplier driven non-conformances and manage the timely closure of NC’s within Trackwise.
  • Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.

Job Requirements:

Qualification & Experience:

  • Strong in critical thinking and “outside the box” thinking.
  • Ability to represent Quality function with project teams.
  • Bachelor’s Degree in Engineering
  • Familiar with GD&T (Geometric Dimensioning and Tolerancing)
  • Demonstrated ability to successfully manage and complete projects in a matrix organization.
  • Demonstrated ability to work independently and as part of cross-functional teams.
  • Familiar with metrology (i.e. calipers, micrometers, pin gages, CMM (coordinate measuring machine), etc.)
  • Strong interpersonal skills, written, oral communication and negotiations skills.
  • Machining background/experience is a plus (lathe, mills, etc.)
  • MS, CQE, or CRE preferred.
  • Familiarity with ISO 13485, GDP, GMP desired.
  • Experience in interacting with regulatory agencies (FDA, TUV, etc.) desired.
  • Six Sigma Green or Black belt preferred.
  • Understanding of US and International Medical Device Regulations.
  • Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
  • 2+ years of experience
  • Highly developed problem-solving skills. Strong analytical skills.
  • Previous medical device industry experience desired.
  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
  • Previous experience using CAD Software

Job Details:

Company: Stryker

Vacancy Type:  Full Time

Job Location: Kalamazoo, MI, US

Application Deadline: N/A

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