Staff Quality Engineer en Cary, IL a Stryker Corporation

Fecha de publicación: 9/16/2019

Resumen de la oferta

Descripción del empleo

Who we want

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

We are a leading developer of products used to prevent hospital-acquired conditions such as ventilator-associated conditions, skin injury due to incontinence, pressure injuries, surgical site infections and healthcare worker injury across the continuum of care. From the acute care setting to the skilled nursing and long-term care setting, as well as continued care at home, we create products that make care giving easier and provide clinical outcomes. Our success is supported by a unique culture that is summed up in the phrase, “keep it personal”. It’s our way of reinforcing a focus and commitment to our employees and customers through integrity, honesty and passion.

As a Staff 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:

  • Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within Trackwise.
  • Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.
  • Disposition non-conforming product by leading MRB activities and issuing NC's as appropriate.
  • Performs PPAP activities for supplier changes.
  • 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

Basic Qualifications:

  • Bachelors Degree in Engineering or science related field
  • Minimum 5 years work experience in engineering, quality, manufacturing, pharmaceuticals or regulatory

Preferred Qualifications:

  • ASQ Certified Quality Engineer or similar certification preferred
  • 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: 10%

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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