Senior Internal Quality Auditor

Stryker; Cork; Hybrid; EUR 49,000 - 82,000; Full time

Benefits offered by this job

40% travel

Job summary

Stryker is seeking a qualified Internal Audit professional to lead audits across global sites. The role emphasizes collaboration with GQO and site stakeholders, interpretation of FDA/ISO/MDD requirements, and reporting of findings to drive quality improvements.

The position requires a strong regulatory background, excellent communication, and the ability to operate in a highly regulated environment with 40% travel. Hybrid or onsite work available in Ireland.

Qualifications

• Bachelor’s degree or equivalent experience.
• Minimum of 2+ years medical device or regulated industry experience.
• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Directive Regulation (93/42 EEC).
• Excellent communication skills at all levels, both written and verbal (English).
• Solid knowledge of manufacturing processes, statistical techniques, validation, sterilization, environmental controls and basic regulatory requirements for medical devices.

Responsibilities

• Lead Internal audits from planning, execution, closure, reporting, and post-audit follow-up with minimal oversite.
• Plan and tailor the audit agenda and scope based on feedback from the site.
• Interpret and provide guidance on applicable regulations (FDA, ISO, MDD).
• Assist in coordinating the Internal Audit program to ensure compliance to quality system requirements.
• Present audit results and data to site stakeholders.
• Escalate emerging trends of audit findings to identify areas for improvement.
• Interface with Site RAQA Heads and GQO Management where applicable.
• Monitor observations from external and Corporate quality audits.

Skills

Audit planning

Regulatory knowledge

Communication

Audit reporting

Stakeholder collaboration

Education

Bachelor’s degree or equivalent

Tools

Lead Auditor Certification

Job description

Work Flexibility: Hybrid or Onsite

This is a permanent hybrid role with full Stryker benefits and 40% travel.

What you will do:

The person in this position is responsible for working collaboratively with key stakeholders from new and existing Global Quality and Operations (GQO) Stryker sites in the planning, execution and reporting of Internal Audits. It is critical for this person to quickly build strong relationship throughout Stryker’s global footprint. This individual must possess very strong written and oral communication skills and be able to report findings throughout all levels of the organization in a collaborative and fact-based manner that is conducive to building strong partnerships. A keen understanding of the highly regulated environment, great attention to detail, and the ability to make important decisions independently are requirements of the position.

• Lead Internal audits from planning, execution, closure, reporting, and post-audit follow-up with minimal oversite
• Plan and tailor the audit agenda and scope based on feedback and information received from the site being audited
• Interpret and provide guidance on applicable regulations such as FDA, ISO, MDD and Stryker policies
• Assist in the coordination of Stryker Internal Audit program to ensure compliance to quality system requirements
• Present audit results and correlating data to key stakeholders at the site location
• Escalate emerging trends of audit findings to identify areas for improvement
• Interface with Site RAQA Heads, GQO Quality Management and International RAQA Management, where applicable
• Monitor observations from external and Corporate quality audits of Stryker sites.

What you will need:

• Bachelor’s degree or equivalent experience required
• Minimum of 2+ years medical device or regulated industryexperience
• Lead Auditor Certification Required
• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, Medical Device DirectiveRegulation (93/42EEC), and other national and international regulations.
• Excellent communication skills at all levels, both written andverbal (English)
• Performs in a professional manner and represents the group in away that is collaborative and promotes a positive image while buildingeffective relationships with customers and stakeholders
• Solid knowledge of manufacturing processes, statisticaltechniques, validation, sterilization, environmental controls and basicRegulatory requirements for medical devices

Ireland Pay Ranges:

• Ireland : €49,000 - €82,000 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: 40%