Senior Internal Quality Auditor

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

Benefits offered by this job

40% travel

Job summary

Stryker in Ireland seeks a Lead Internal Auditor to collaborate with GQO sites worldwide and manage audits from planning to post-audit follow-up. You will build strong relationships across the global footprint and report findings at all levels.

The role requires a Bachelor's degree, 2+ years in a regulated industry, and Lead Auditor Certification. Expect 40% travel and a comprehensive benefits package in a hybrid work model.

Qualifications

• Bachelor's degree or equivalent experience required.
• Minimum of 2+ years medical device or regulated industry experience.
• Lead Auditor Certification Required.
• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Directive Regulation (93/42/EEC), and other national and international regulations.
• Excellent communication skills at all levels, both written and verbal (English).
• Performs in a professional manner and represents the group in a collaborative and positive way with customers and stakeholders.
• 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 oversight.
• Plan and tailor the audit agenda and scope based on feedback from audited site.
• Interpret and provide guidance on applicable regulations such as FDA, ISO, MDD and Stryker policies.
• Assist in coordinating Stryker Internal Audit program for quality system compliance.
• Present audit results and data to stakeholders at site location.
• Escalate emerging trends of audit findings to identify improvement areas.
• Interface with Site RAQA Heads, GQO Quality Management and International RAQA Management.
• Monitor observations from external and Corporate quality audits of Stryker sites.

Skills

Communication skills

Independent decision making

Stakeholder collaboration

Education

Bachelor's degree or equivalent experience

Job description

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.

If you'd like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.

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.