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

掲載日付: 1/25/2020



Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • 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.

What you will do

As a Senior Quality Assurance Engineer you will be responsible for complaint handling, reliability improvement, quality management, continuous improvement, quality systems engineering, project management and regulatory compliance. 

Quality Management / Quality Systems / Continuous Improvement:

  • Support Operations – Ongoing support of critical quality issues as needed
  • Deliver Exceptional Customer Service regarding timely investigation of manufacturing related complaints
  • Execute monthly data analysis and trending to support Quality Plan and drive visibility to opportunity for improvement
  • Statistical Support – Provide expertise regarding Sample size selection, SPC, DOE, etc.
  • Provide Supplier Quality support for issues immediately impacting the business
  • Assess impact of and disposition supplier-initiated change requests in a timely fashion
  • Support ECO & CAPA processes to ensure thorough and robust outcomes
  • Lead Quality centric problem solving 8D’s and CAPA’s
  • Identify through data mining and analysis opportunities for improvement in particular as it relates to human error

Regulatory Compliance:

  • Participate in internal compliance audits – FDA, ISO, and Internal Audits
  • 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

What you need

  • Bachelor’s Degree in engineering or related field
  • Minimum of 3-5 years of experience in field of specialization
  • Six Sigma Green Belt or ASQ Certified Quality Engineer ideal
  • Manage projects in a timely manner
  • Ability to conduct and document technical investigation
  • Experience with GD&T and Statistical Analysis Capability

Work From Home: No

Travel Percentage: None

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.