Staff Quality Process Engineer in Lakeland, FL at Stryker Corporation

Date Posted: 9/26/2019

Job Snapshot

Job Description

Who We Want:

We are looking for critical thinkers who are enthusiastic about product and process quality and continuous improvement. We seek a highly engaged, detail oriented and self-motivated individual to join our team located in Lakeland, FL. This role will require someone that possesses the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization.

What you will do:

As a Staff Quality Process Engineer you will be responsible for the analysis and resolution of production issues through detailed root cause investigations driving collaboration with operations, engineering and supplier quality engineering teams. You will mentor and drive investigation, monitor process data and trends, coming up with solutions to improve customer satisfaction via product quality. You must exhibit a commitment to quality first culture, compliance and continuous improvement.

You will work closely with operations and the business functions to ensure quality performance of product and processes.
You will collaborate with Divisional QA, cross functional, and supplier teams to address top quality issues.
You will own internal and supplier non-conformances and manage the timely closure of NC's.

You will own and drive internal CAPAs and manage to timely root cause investigation, implementation and closure.
You will lead and collaborate with suppliers regarding non-conformances, supplier corrective action requests (SCARs) as required.
You will engage in the development and improvement of internal manufacturing processes for existing  products.
You will perform critical assessment of internal and supplier proposed change management activities.

You will perform  PPAP activities for supplier changes
You will maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
You will support and drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
You will develop understanding of risk management practices and interface in internal and external audits providing subject matter expertise.                                                     

You will be responsible for internal containment, support of Commercial Holds and drive continuous improvement actions to reduce manufacturing defects.                            

What you need:

  • BS in a science, engineering or related discipline.
  • MS, CQE, or CRE preferred
  • Six Sigma Green or Black belt preferred
  • Minimum of 5 years’ experience required
  • Experience in a regulated setting and experience interacting with regulatory agencies highly desired.
  • Familiarity with ISO 13485, GDP, GMP desired
  • Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics) desired

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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