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NC / CAPA Specialist in Durham, NC bei Stryker Corporation

Datum der Veröffentlichung: 4/22/2019



Position Summary:

Responsible for reviewing and evaluating corrective/preventive actions (CAPA) and the CAPA effectiveness program and communicating CAPA status to cross-functional departments and management. Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Participates in good laboratory practices training of functional areas and assists in the development of training sessions. Ensures that privacy and security standards are met and adhered to. May coordinate activities and assist with interactions during regulatory agency inspections. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Assists with the corrective action implementation. May coordinate investigator site and clinical supplier vendor audits.

Key Responsibilities:

  • Participate in identifying the need for a CAPA to address non-conformance.
  • Develop/review metrics for adverse trending analysis of non-conformities.
  • Support Cross Functional Teams in the investigations of non-conforming events and CAPA implementation.
  • Review and evaluate CAPAs associated with non-conformance and regulatory audits.
  • Review CAPAs to determine their effectiveness.
  • Develop and provide metrics for CAPA status.
  • Ensure on-time completion of CAPAs.
  • Identify opportunities for continuous improvement.
  • Interact with FDA and other regulatory agencies, as required.
  • Work from verbal and/or written instructions.
  • Knowledge of applicable international regulations and standards (QSR, MDD, ISO 13485, CMDCAS, etc.) and willingness to train others in quality assurance/GMP-related topics.
  • Create / Revise SOPs associated with CAPA systems.
  • Provide training for compliance to CAPA procedures.

Basic Qualifications:

  • Bachelor’s Degree is required
  • Minimum 2 years quality, operations or manufacturing environment or related experience required

Preferred Qualifications:

  • Bachelor’s Degree in Engineering or Sciences (mechanical, electrical, industrial, software, computer, biology, physics, chemistry) preferred.
  • 2+ years quality, operations or manufacturing environment experience preferred

Travel: 10%

Work From Home: No

Travel Percentage: None

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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