Staff Specialist, Quality Management Systems

Stryker; Cork; Hybrid; EUR 54,000 - 90,000; Full time

Benefits offered by this job

Full benefits

Job summary

Stryker Ireland is seeking a Staff Specialist, Quality Management Systems (QMS) to lead the development and maintenance of our QMS in compliance with FDA, ISO, EU MDR and country requirements. This 12-month maternity leave cover is hybrid or onsite at Anngrove site, Carrigtwohill, with full Stryker benefits.

You will oversee QMS performance, manage internal and external audits, support training, and drive improvements to align with corporate strategy and regulatory expectations.

Qualifications

• Develop and maintain QMS in accordance with regulatory requirements.
• Drove QMS compliance with FDA, ISO, EU MDR and country regulations.
• Lead internal and external audits and ensure readiness for certification.

Responsibilities

• Develop and maintain the QMS per regulatory requirements.
• Ensure QMS compliance with internal/external regulations (FDA, ISO, EU MDR).
• Manage internal and external audits and liaise with notified bodies.

Skills

Quality management

Regulatory affairs

Audits

Education

Bachelor's in science/engineering (Level 8)

EQF Level 6 or EU equivalent

Job description

Work Flexibility: Hybrid or Onsite

This is a 12 months maternity leave cover -

Hybrid role in our Anngrove site, Carrigtwohill with full Stryker benefits.

What you will do:

• The Staff Specialist, Quality Management Systems (QMS) will be primarily responsible for the development of the quality management system in accordance with relevant regulatory requirements for medical devices.
• The Staff Specialist, QMS will oversee and ensure that an effective and efficient quality management system is built and maintained. Has responsibility to ensure all necessary QS regulations are met in order to receive regulatory clearance/ certification.
• Responsible for QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, EU MDR, and individual country requirements).
• Responsible in developing the optimum state of QMS for current and future business needs, aligned with Corporate, divisional & GQO QMS.
• Control and implementation of the development or modification of Stryker's regional/local quality management system
• Support management and coordination of management reviews and quality planning reviews
• Support in identifying and implementing strategic improvements and participation in the quality planning process
• Serve as a Local Process Owner for local Quality System Processes
• Responsible for the management of internal and external audits, leading preparations and back room
• Liaise with notified bodies to manage certification changes.
• Support the implementation of QMS training
• Initiate and support the development, maintenance, and improvement of policies and procedures.
• Assessment and quantification of the requirements of the QMS so that it offers the optimal structure for the services to be provided
• Implementation of best-in-class QS practices and benchmarking against industry leads and regulatory requirements.
• Ensure overall GMP and GDP compliance within Quality.
• Management and implementation of projects to develop and/or modify Stryker's regional/local QMS, as well as providing direction for the strategy to the entire project team

What you will need:

• Bachelor's Degree - Level 8 Science or Engineering
• EQF Level 6 or equivalent - EU
• Minimum 4 years of experience in a Quality/Regulatory Affairs function

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.

Travel Percentage: 10%