Senior Staff Specialist, Change Management

Stryker Group; Cork; Hybrid; EUR 62,000 - 105,000; Full time

Job summary

Stryker Group in Ireland is seeking a Senior Staff Specialist, Change Management for a permanent Hybrid role at Springhill. You will lead changes to the quality management system, provide technical guidance, and drive improvement across local and franchise levels.

You will manage Change Control forums, mentor teams, and coordinate audits and KPI reporting to ensure regulatory compliance and business performance.

Qualifications

• Bachelor’s Degree Sciences or Engineering (Level 8).
• Minimum 6 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

• Leading and reviewing changes to processes and procedures with attention to regulatory compliance.
• Lead & execute Change Control forums in multisite and global forums.
• Act as SME on change control procedures and systems (OnePLM, Agile); franchise Change Control Process Owner.
• Provide input to global procedures and future changes in QMS.
• Mentor change owners and initiators.
• Manage site change control KPIs including reporting for quality and business review bodies.
• Develop Change Control KPIs and support process improvements.
• Lead audit preparation for all areas of QMS and mentor teams in audit performance.
• Support training in change control process and systems delivery and access.
• Drive continuous improvement to increase efficiency of QMS and participate in cross-site projects.
• Participate in optimization of interfaces in projects like production transfers, mergers and acquisitions.

Education

Bachelor’s Degree Sciences or Engineering (Level 8)

Job description

This is a a permanent Hybrid role based in our Springhill site.

What you will do:

The Senior Staff Specialist, Change Management will be responsible for providing leadership, technical guidance & assessment of changes to the quality management system at a local and franchise level.

The Senior Staff Specialist, Change Management will be responsible for leadership and direction of high complexity projects 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 in all Change Control review forums and in multisite 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, Acts as the franchise Change control Process Owner, ensuring compliance to the relevant Corporate and local procedures.
• Provides review and futuristic input into global procedures
• Expert in 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. Lead teams through all stages of the change control process. Mentors 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
• Provide input to the development of Change Control KPIs including reporting requirements, identify & support process improvements.
• Lead/coordinate audit preparation for all areas of QMS. Act as SME in Change Control for Stryker Internal, Corporate and third party compliance audits. Mentor team members in Audit performance
• Support design & develop training in change control process. Manage delivery, maintenance of training and access to all users of change control process & systems
• Drive identification and implementation of continuous improvement opportunities to increase the efficiency and effectiveness of the Quality Management Systems. Lead initiatives for continuous improvement. Participate in multi-site and corporate project teams in areas of change management and quality systems improvement
• Participation in the optimization of (internal and external) interface processes within important projects and initiatives such as production transfers, mergers and acquisitions

What you will need:

• Bachelor’s Degree Sciences or Engineering (Level 8)
• Minimum 6 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: €62,000 - €105,000 EUR Annual

At 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.