Senior Internal Auditor BGS Vertical Lift (Quality Systems Specialist) Company: The Boeing Company Boeing Global Services (BGS) is looking for a Senior Internal Auditor BGS Vertical Lift (Quality Systems Specialist) to join their Vertical Lift Quality Team in Mesa, AZ. This position will focus on supporting Vertical Lift Quality organization. Position Responsibilities: · Create and maintain the site Internal Audit Schedule · Maintain the site Internal Audit Program per AS9100 requirements · Promotes a healthy Quality Management System (QMS) rooted in process-based management methodologies · Performs process risk assessments · Writes Internal Audit reports and documents process non-conformance · Support process owners with corrective action process requirements · Performs and oversees Internal Audits – conduct assessments of processes and practices for comparison to applicable standards and requirements. · Maintain Internal Audit monthly metrics/KPIs · Provide monthly Internal Audit performance to the DQMR · Identified as the Process Owner for the Internal Audit Program that resides in the local Quality Management System · Align CAPA process with company and AS9100 requirements for Corrective Actions · Recommend and implement changes to the existing Internal Audit Program · Assist our business unit across Vertical Lift sites with continuous improvements and or lean projects · Use data for analysis trends and opportunities for improvement · Use experience and knowledge relative to all methods of Root Cause Corrective Actions, e.g., 5-Why, Fish bone, Boeing Problem Solving Model (BPSM)</
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Role overview
Job description
Stryker is hiring a Senior CAPA Specialist for the Joint Replacement division 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 extension requests.
What you will do
· As Problem Solving Methodology expert, facilitate 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
- Bachelor’s 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).
$87,000 - $145,100 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 contractor’s legal duty to furnish information.
What they are looking for
Skills & requirements
Qualification
Bachelor’s degree or higher in science, Engineering or applicable technical field
Hiring company
Stryker
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