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Senior Quality Engineer in Cary, IL bei Stryker Corporation

Datum der Veröffentlichung: 4/11/2019

Stellenauszug

Stellenbeschreibung

Who we want

  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes
  • 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 Engineer, you will be a key member of the Quality Operations team ensuring the safety, efficacy, and compliance with industry practices. Working closely with Operations, Planning, Marketing, Advanced Operations, and Regulatory Affairs team members building strong relationships by fostering open communication, respect, and trust. This role is in a fast paced, high volume environment with opportunity for growth and leadership development.

Responsibilities:

  • Design and/or implement standard methods and procedures for inspecting, testing, and evaluating the precision and reliability of products.
  • Develop and execute standard processes, product protocols, and author technical documents including test protocols, reports and engineering studies.
  • Provide statistical rationale for sample size analysis of test data.
  • Analyze, design, and/or improve standard manufacturing procedures.
  • Root Cause investigations following 4D methodology and determining effective Corrective / Preventative Actions.

What you need

  • Bachelor's Degree in Engineering, Science, Quality or equivalent discipline is required.
  • ASQ Certified Quality Engineer or similar certification preferred.
  • 5+ years’ experience in a Quality position.
  • Proficient understanding of Pharmaceutical / Medical Device manufacturing processes, FDA CFR 210, 211, and 820, ISO 13485, ICH Q7/Q10.
  • Lean Six Sigma/Investigation (CAPA) training.
  • High level knowledge/experience of risk based and statistical techniques; process risk, statistical sampling plans, process capability, and Gage R&Rs

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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