Senior Quality Engineer - Mahwah, NJ - Stryker Corporation

Date de publication : 9/14/2019

Résumé de l'offre

Description de l'offre

Who we want


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.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do

As a Senior Quality Engineer, under the direction of the manager and staff/principal engineers, you will conduct/perform documented failure investigations on customer complaints leading to the timely identification of root cause and corrective/preventive actions.  You will also be responsible for identifying continuous improvement initiatives to drive process efficiencies.

Responsibilities:

  • Mentor junior analysts and engineers by providing technical training and coaching to colleagues about Stryker’s product portfolio and business procedures.
  • Identify continuous improvement initiatives to drive process efficiencies.
  • Work in a team environment with members of the complaint handling group to achieve business metrics.
  • Generate team metrics and present at meetings on team progress.
  • Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action.
  • Participate in and/or organize a cross functional team to help identify problem issue and drive product improvement process.
  • Provide support to the new product development and risk management process.
  • Work with all product, manufacturing and quality teams to determine root cause and to ensure proper corrective actions have been identified, implemented and verified to be effective.
  • Generate data for Competent Authorities (FDA, BSI and other regulatory bodies).
  • Collaborate with legal counsel for patient claims and cases.
  • Collaborate with consulting clinicians on medical dictations.
  • Train sales representatives on PER process.
  • Attend job-pertinent training classes. 

What you need

Basic Qualifications:

  • Bachelor’s Degree
  • Minimum 3 years’ experience in quality, manufacturing or engineering

Preferred Qualifications:

  • Master’s Degree in engineering or science related field
  • Prefer experience with medical device product development life cycle, including risk management and design/ process verification & validation
  • Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
  • CQE certification and Six Sigma Green or Black Belt

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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