Senior Engineer Non-Conformance/CAPA in Mahwah, NJ at Stryker Corporation

Date Posted: 11/17/2019

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care.  The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.  We are currently seeking a Senior CAPA Specialist located in Mahwah, New Jersey.

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.

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.

What you will do:

  • Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
  • Installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates.
  • Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems
  • Ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.
  • Ensure compliance to CAPA processes and procedures.
  • Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.
  • Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC/CAPA process.
  • Ensure users provide necessary rigor to the eCAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner.
  • Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, etc.).
  • Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.
  • Ensure adequate training is maintained, and provided to all users of CAPA process and systems
  • Lead and participate in cross-site and corporate project teams in areas of CAPA and quality system improvement.
  • Support Stryker internal, Corporate, and third-party audit activities.
  • Qualifications, skills and desirable experience:

What you need:

  • BS in a science, engineering or related discipline.
  • 3+ years of experience
  • Preferred working knowledge and understanding of U.S. and International medical device regulations and supporting Quality Systems (audits, management review, quality planning, etc.)
  • Must possess strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously.
  • Strong written and oral communication and negotiation skills.
  • Strong critical thinking skills.
  • Highly developed problem-solving skills.
  • Strong analytical skills.
  • Demonstrated ability to successfully manage and complete projects in a matrix organization.
  • Demonstrated ability to work independently.

Work From Home: Occasional

Travel Percentage: 20%

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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