Staff Specialist, Change Management

PowerToFly; Cork; On-site; EUR 54,000 - 90,000; Full time

Job summary

Stryker Ireland is seeking a Staff Specialist, Change Management for a permanent hybrid role at the Springhill site. The role oversees changes to the quality management system and leads change control board activities across sites.

You will serve as SME on change control procedures, train teams, and ensure compliance with ISO 13485, MDSAP, and CFR Part 820 while collaborating with Design, Quality and Operations teams.

Qualifications

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

Responsibilities

• Act as change analyst & approver with review for completeness and regulatory compliance
• Lead & execute the change control board review forums across sites
• Serve as SME on change control procedures and systems (OnePLM, Agile)
• Provide input into global procedures and ensure QMS alignment
• Collaborate with divisions and departments on product/process/supplier changes
• Mentor teams through all stages of the change control process
• Manage site change control KPIs and present updates for governance bodies
• Coordinate audit preparations and act as SME in change control for audits
• Ensure training is developed for all change control users
• Identify opportunities for quality data improvements and process optimization

Skills

Quality/Regulatory Affairs experience

Regulatory knowledge (ISO 13485, MDSAP

Education

Bachelor's Degree in Sciences or Engineering

Tools

OnePLM

Agile

Job description

This 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 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.