Senior Internal Quality Auditor

Stryker Corporation; Cork; Hybrid; Confidential; Full time

Benefits offered by this job

Hybrid work model

Stryker benefits package

Job summary

Stryker in Cork, Ireland, seeks a Senior Internal Quality Auditor to partner with GQO sites worldwide, leading planning, execution, and reporting of internal audits with strong stakeholder collaboration. Requires Lead Auditor Certification and 2+ years in a regulated medical-device environment, plus excellent written and spoken English.

Expect 40% travel and a hybrid/onsite schedule with comprehensive benefits; you will interpret FDA/ISO regulations and drive continuous improvements across the

Qualifications

• Lead Auditor Certification required.
• Minimum 2+ years in medical device or regulated industry.
• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, and Medical Device Directive (93/42/EEC).
• Excellent written and verbal communication at all levels.

Responsibilities

• Lead internal audits from planning to post-audit follow-up.
• Plan and tailor audit agendas based on feedback from audited sites.
• Interpret and provide guidance on applicable regulations (FDA, ISO, MDD).
• Present audit results to site stakeholders and correlate data.
• Escalate emerging trends to identify areas for improvement.

Skills

Lead Auditor Certification

Regulatory knowledge

Communication skills

Quality systems

Education

Bachelor’s degree or equivalent

Job description

## Senior Internal Quality AuditorApply: Cork, Carrigtwohill IDA Business & Technology Park Tullagreen: Full time: Posted Today: R572664Work 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 industry experience* Lead Auditor Certification Required* Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Directive Regulation (93/42EEC), 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 way that is collaborative and promotes a positive image while building effective relationships with customers and stakeholders* Solid knowledge of manufacturing processes, statistical techniques, validation, sterilization, environmental controls and basic Regulatory requirements for medical devices**Ireland Pay Ranges:*** **Ireland**: €49,000 - €82,000 EUR AnnualAt 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.Travel Percentage: 40%