Quality Assurance Engineer - QAE in Portage, MI at Stryker Corporation

Date Posted: 8/6/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Portage, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/6/2018
  • Job ID:
    R402408

Job Description

Position Summary Responsible for complaint handling, reliability improvement, quality management, quality systems, continuous improvement, quality systems engineering, project management and regulatory compliance. Knows and applies the fundamental concepts, practices and procedures of the quality specialization. Essential Duties & Responsibilities Complaint Handling

  • Deliver Exceptional Customer Service to Complaint Originator
    • Resolve Potential MDR Investigations
    • Close Complaint Investigations
    • Champion Root Cause Problem Solving
    • Perform Risk Analysis and Reduction
    • Author Quality / Regulatory Technical Reports (QRTR’s)
    • Lead Customer Contact – Phone calls, letters, visits
    • Draft monthly bulletins to Field Service Reps on the status of quality and improvements made

Reliability Improvement

  • Trend service reports to identify top product issues and drive resolution
  • Quality Management/ Quality Systems / Continuous Improvement
  • Support Operations – Ongoing support of critical quality issues as needed (ex: ship hold)
  • Lead Quality Planning – Create and drive Quality Plan for Business Unit with COE Quality Leader
  • Business Unit Highlights – Monthly data analysis and trending to support Quality Plan (ex: prep data)
  • Statistical Support – Lead Sample size selection, SPC, DOE, etc.
  • Support SQE’s (as needed)
    • Material Review Board (MRB)
    • Fabrication – Tooling Certification, Gage Plans, Gage R&R, Validation Support
    • Vendor Management – Identify vendor quality issues and drive improvements
  • Cost Reduction Team Support – Support initiatives as needed
  • Special Projects – As needed by Business Unit and Department
  • Support ECO & CAPA processes to ensure thorough and robust outcomes and enforce quality compliance (ex: Gage plans, FA, etc)
  • Lead Quality centric problem solving 8D’s and CAPA’s

Quality Systems Engineering & Project Management

  • Identify opportunities for enhancement of existing quality and regulatory systems/tools in support of our departmental and divisional visions.
  • Provide quality support as a consultant to our organization to build understanding of quality concepts and drive our quality culture.
  • Support AQE’s (as needed):
    • Provide engineering specification and product design support to R&D teams through robust design practices (GD&T, etc)
    • Participate in drawing development
    • Develop control plans and inspection procedures
    • Support GR&R with Metrology Specialist & AQT
    • Participate in new product development process acting as a feedback loop from the field
  • Regulatory Compliance
  • Conduct Monthly Spider Web Audits and Quarterly Team Audits as required
  • Participate in internal compliance audits – FDA, ISO, and Internal Audits
  • Support external audits – Vendor and Sister Divisions
  • Monitor compliance to Medical Quality Procedures and FDA Quality System Regulations (QSR’s) and update as necessary
  • Regulatory Training – Conduct and support training on QSR’s, ISO, and RA Topics
  • Monitor the ECO & CAPA processes meet all compliance requirements (ex: Write it Right!)

    Education

    • Bachelors Degree in Engineering or related field
    • GPA of 3.0 or higher, strongly preferred

    Qualifications & Experience

    • Achieved a limited (learning) level of industry knowledge
    • Competent with Microsoft Office (Outlook, Excel, Word, etc.)
    • Must possess excellent oral and written communication skills
    • Ability to solve problems in a high stress situation
    • Possess attention to detail
    • Eagerness to assist internal and external customers
    • Manage projects in a timely manner
    • Ability to conduct and document technical investigation
    • Experience with GD&T and Statistical Analysis Capability, highly desirable

    Physical Requirements

    • May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate
    • May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities
    • Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability
    • Requires use of safety glasses in designated areas
    • Closed-toe shoes must be worn on the production floor; safety shoes are recommended


    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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