Staff Specialist, Change Management

Stryker Corporation; Cork; Hybrid; Confidential; Full time

Job summary

Stryker Corporation in Cork, Ireland is hiring a Staff Specialist, Change Management. The role oversees changes to the quality management system, leading cross-site projects and acting as a subject matter expert on change control procedures.

You’ll drive improvements while ensuring regulatory compliance and training across users of change control tools. The position requires a bachelor’s degree in sciences or engineering and at least four years in quality/regulatory affairs, with strong

Qualifications

• Bachelor’s degree in Sciences or Engineering.
• Minimum 4 years experience in a Quality/Regulatory Affairs function.
• Profound knowledge and understanding of US, European and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired).

Responsibilities

• Oversee and assess changes to the quality management system.
• Lead and direct moderate complexity projects with cross-site stakeholders.
• Act as change analyst & approver for processes and procedures with compliance focus.
• Lead change control board review forums and participate in multi-site/global forums.
• Serve as SME on change control procedures and related systems (OnePLM, Agile).
• Provide training and coaching on change control processes and monitor KPIs.
• Coordinate audit preparation for functional areas and support audits.
• Drive continuous improvement and collaboration to optimize business processes.

Skills

Change Management

Quality Systems

Regulatory Affairs

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Sciences or Engineering

Tools

OnePLM

Agile

Job description

## Staff Specialist, Change ManagementApply: Cork, Ireland: Full time: Posted Today: R573153Work Flexibility: Hybrid or OnsiteThis is a a permanent Hybrid role based in our Springhill site.**What you will do:**The Staff Specialist, Change Management, will be responsible for the oversight & assessment of changes to the quality management system.The Staff Specialist, Change Management will be responsible for leadership and direction of moderate complexity projects, which require considerable resources and Interfaces with stakeholders and end users with the goal of continuously evolving our quality and business performance* Acting as change analyst & approver, have responsibility for review and approval of changes to processes and procedures, with attention to detail, review for completeness, accuracy, effectivity, appropriateness and compliance to regulatory standards.* Lead & execute the change control board review forums. Participate in multi-site and global forums.* Act as a subject matter expert on all change control-related procedures, ensuring compliance with the relevant procedures and serve as a super-user on relevant systems (OnePLM, Agile) Additional, may be the franchise Change control Process Owner ensuring compliance to the relevant Corporate and local procedures.* Provides review and input into global procedures.* In-Depth understanding of change management role and interaction with the entire QMS* Collaborates with Division & GQO sites, and functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes.* Facilitate and mentor teams through all stages of the change control process. Supports and coaches the change owners and initiators\"* Manage and monitor site change control KPIs including reporting requirements, presenting detailed updates and information to support quality and business review bodies and collaborate with other GQO sites to ensure compliance with global requirements and metrics are achieved* Lead/coordinate audit preparation for functional area. Act as SME in change control for Stryker Internal, Corporate and third party compliance audits* Ensure adequate training is developed, maintained and provided to all users of change control process & systems* Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results. Support in multi-site and corporate project teams in areas of change management and quality systems improvement**What you will need:*** Bachelor’s Degree Sciences or Engineering* Minimum 4 years experience in a Quality/Regulatory Affairs function* Profound knowledge and understanding of US, European and International Medical Device* Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired)**Ireland Pay Ranges:*** **Ireland**: €54,000 - €90,000 EUR AnnualAt Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.Travel Percentage: None