Senior Quality Engineer - Metallurgy in Kalamazoo, MI at Stryker Corporation

Date Posted: 7/27/2018

Job Snapshot

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

Job Description

"Position summary: Provide quality engineering support for metal injection molding and machining of components. Will also provide direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards. 

Essential duties & responsibilities: (detailed description)

  • Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
    • Work closely with operations and the business functions to ensure quality performance of product and processes.
    • Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
    • Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
    • Analysis and review of concession requests.
    • Review and approval of change management activities.
    • Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
    • Will assist during new product development with validation support for product, processes, packaging, software, and sterilization. Will then transfer these requirements to sustainable production development.
    • Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.

  • Develop robust efficient inspection strategies to ensure parts produced meet metallurgical specifications. Will develop part and product inspection methods, sampling plans and procedures which will involve use of:
    • Statistical process control
    • Incoming part/product inspection criteria
    • Automated testing
    • Functional gauging
    • Productivity improvements
  • 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.
  • Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
  • Will partner with supplier quality to troubleshoot supplier process related problems and improvement opportunities.
  • Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
  • Assist in the development, responsible for review & approval of process and equipment validation/qualification.
  • Support manufacturing transfers to other plants/facilities, leading quality activities.
  • Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
  • Coach and mentor others in quality topics and activities.

Education & special training:  

  • Bachelor of Science, Engineering or related subject with 2 or more years of experience in a quality discipline
  • Masters of Science, Engineering or related subject preferred.
  • Experience in Metallurgy or Materials Science is preferred.
  • CQE or equivalent course work / experience desirable.

  Qualifications & experience:

  • Previous experience in a regulated environment desirable.
  • Project management experience desirable.
  • Proficient in understanding of Medical Device manufacturing processes desirable.
  • Validation experience.
  • Experience at heat treating facility or metallography lab experience preferred.
  • Experience in Metallography lab experience preferred including use and interpretation of any or all of the following tests: SEM, Microhardness & Microstructure, and X-Ray Defraction.
  • Proficiency in statistical methods and application.
  • Familiarity with ISO 13485, GDP, GMP desirable.
  • Excellent communication skills and attention to detail.
  • Have a good understanding of engineering and quality practices & methods.
  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
  • Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
  • Must be willing to work as part of a multi-site team, with some travel required.
  • Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
  • Highly developed problem solving and strong analytical skills.
  • Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
  • Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
  • Manages change well and adopts a continuous improvement orientation to the role
  • Ability to be the voice of Quality when dealing cross functionally

    Physical & mental requirements:

  • Job demands include prolonged sitting, may need to stoop, bend and stand as appropriate.
  • Requires coordination of hands and/or eye/hand/foot.
  • Meets cognitive demands to include visual discrimination/memory, auditory discrimination/memory reading ability, independent decision making and retention of specific knowledge.
  • Requires use of safety glasses, and possible other Personal Protective Equipment, in designated areas.
  • Requires 24/7 reachability and communications in order to support all facets of the EH&S system
  • May require various, temporary work locations

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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