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      Urgent! Manager, Medical Device and Combination Product Quality Systems - Local Job Opening in Westport
 
                        
                         
  
  
Company Description
  
  
  
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .
  
  
  
Job Description
  
  
  
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products.
This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
  
  
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
  
  
Responsibilities:
  
  
  
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
  
  
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
  
  
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
  
  
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
  
  
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
  
  
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
  
  
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
  
  
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
  
  
  
  
Qualifications
  
  
  
  
+ Bachelor’s degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
  
  
+ ISO 13485 Lead Auditor certification by a professional body is preferred.
Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
  
  
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time.
The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
  
  
  
This is a hybrid role with 3 days on site, 2 days remote.
  
  
  
Additional Information
  
  
  
  
  
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
 Equal Opportunity Employer/Veterans/Disabled.
  
  
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
  
  
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
  
  
https://www.abbvie.com/join-us/reasonable-accommodations.html
  
                      
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Unlock Your Manager Medical Potential: Insight & Career Growth Guide
Real-time Manager Medical Jobs Trends in Westport, Ireland (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Manager Medical in Westport, Ireland using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 8414 jobs in Ireland and 17 jobs in Westport. This comprehensive analysis highlights market share and opportunities for professionals in Manager Medical roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! AbbVie is currently hiring and seeking a Manager, Medical Device and Combination Product Quality Systems to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Manager, Medical Device and Combination Product Quality Systems Jobs Westport.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at AbbVie adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Manager, Medical Device and Combination Product Quality Systems Jobs Ireland varies, but the pay scale is rated "Standard" in Westport. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Manager, Medical Device and Combination Product Quality Systems typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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            Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Manager, Medical Device and Combination Product Quality Systems interview at AbbVie, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the AbbVie's products or services and be prepared to discuss how you can contribute to their success.
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