Senior Internal Quality Auditor

PowerToFly; Carrigtwohill; On-site; EUR 49,000 - 82,000; Full time

Benefits offered by this job

Stryker benefits

Job summary

Stryker Ireland is hiring a permanent hybrid Internal Audit professional to lead audits from planning through closure, tailoring agendas to site feedback and applying FDA/ISO/MDD requirements to ensure compliance.

The role requires a bachelor’s degree, 2+ years in the medical device/regulatory sector, and Lead Auditor Certification. It involves collaboration with global RAQA teams and offers full Stryker benefits and 40% travel.

Qualifications

• Bachelor’s degree or equivalent experience.
• Minimum of 2+ years in medical device or regulated industry.
• Lead Auditor Certification is required.
• Solid knowledge of FDA, ISO 13485, and MDD/93/42 EEC regulatory frameworks.
• Excellent written and verbal communication in English.

Responsibilities

• Lead internal audits from planning to closure.
• Tailor audit agenda and scope per site feedback.
• Interpret regulations such as FDA, ISO, and MDD.
• Coordinate Internal Audit program for quality system compliance.
• Present audit results to site stakeholders.
• Monitor and escalate audit findings for improvements.

Skills

Auditing

Regulatory knowledge

Communication skills

Leadership

FDA/ISO knowledge

Education

Bachelor’s degree or equivalent experience

Tools

Lead Auditor Certification

Job description

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

What you will do:

• 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 Requirediece
• 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.

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.