Senior CAPA Specialist

Work Flexibility: Onsite

Stryker is hiring a Senior CAPA Specialist for the Global Quality Operations team supporting the Joint Replacement product portfolio in Mahwah NJ. Working within the QMS team to ensure compliance with CAPA processes and procedures and is responsible to but not limited to. Have responsibility for review and approval of NC and CAPAs with attention to detail review for completeness accuracy effectivity and timeliness. Review & Approval of CAPA changes including execution requests.

What you will do

• As Problem Solving Methodology expertfacilitate and coach NC & CAPA teams in the application of problem-solving techniques and promote its use and development e.g. Human Error Reduction 4-D etc.
• Support Nonconformance (NC) and Corrective and Preventive Action (CAPA) activities by partnering with cross-functional teams to drive timely investigations and resolution of quality issues.
• Apply CAPA root cause analysis and problem-solving methodologies to support effective corrective and preventive actions.
• Maintain accurate and complete CAPA documentation within electronic quality management systems (e.g. TrackWise) ensuring required evidence and records are documented.
• Assist in facilitating CAPA review meetings and contribute to site cross-functional and global quality discussions.
• Monitor CAPA metrics and trends prepare reports and provide data to support quality and business reviews.
• Provide guidance and support to CAPA process stakeholders promoting consistent application of quality system requirements and procedures.
• Participate in training process improvement and continuous improvement initiatives to enhance CAPA effectiveness and compliance.
• Support internal corporate and external audits and contribute to quality system improvement projects and corrective action follow-up activities.

What you need

Required Qualifications

• Bachelors degree or higher in science Engineering or applicable technical field.
• Minimum 2 years experience working in a medical device or pharmaceutical regulated environment.

• Demonstrated experience managing Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes including root cause investigations implementation of corrective actions effectiveness verification and continuous quality improvement initiatives.

Preferred Qualifications:

• Experience in interacting with regulatory agencies (FDA MoH TUV etc.).
• Knowledge of U.S. FDA and international medical device regulatory requirements and quality system standards.
• Experience in supporting Quality Systems (e.g. Audits Management review Quality Planning).

$87000 - $145100 USD Annual

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 contractors legal duty to furnish information.