Senior Staff Specialist, Change Management

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

Job summary

Stryker Ireland seeks a Senior Staff Specialist, Change Management for a permanent hybrid role at our Springhill site in Cork. You will lead changes to the quality management system, guide high-complexity projects, and act as SME for change control processes across local and global forums.

You will collaborate with Design, Quality and Operations on product, process, system or supplier changes; mentor change owners and drive continuous improvement in QMS efficiency.

Qualifications

• Bachelor's Degree in Sciences or Engineering (Level 8).
• Minimum 6 years experience in a Quality/Regulatory Affairs function.
• Profound knowledge of US, European and International Medical Device Regulations (ISO 13485, MDSAP, CFR Part 820).

Responsibilities

• Lead and provide leadership, technical guidance and assessment of changes to the QMS at local and franchise level.
• Direct high-complexity projects to evolve quality and business performance.
• Act as change analyst & approver for changes to processes and procedures with regulatory compliance.
• Lead change control forums, multisite and global forums; mentor change owners and initiators.
• Manage site change control KPIs, reporting, and updates for quality and business reviews.
• Contribute to development of Change Control KPIs and process improvements.
• Lead/coordinate audit preparation for QMS; act as SME in Change Control for audits.
• Support training development for change control processes and systems.
• Drive continuous improvement to enhance efficiency and effectiveness of the QMS.

Job description

This is 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.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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.