Manager, Quality Assurance

Work Flexibility: Onsite

This is a 12 month contract role based in our Tullagreen site in Cork

Position Summary

As leader of a dedicated Quality Operations team for a site (s), provide direction in quality assurance within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Has responsibility for delivering the compliance and business objectives of the function, with primary responsibility to drive engagement and lead the quality team, while ensuring compliance to Stryker Corporate and SGS requirements, Quality System Regulations and standards.

What you will do:

Working within the Quality Operations structure, in a leadership capacity, has responsibility for quality related activities which includes, but not limited to the following:

• Leadership of a high performing quality team, that provides direct support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality.
• Ensure that the organisation’s conformance and commitment to producing products meets or exceeds customer requirements and the relevant regulatory standards.
• Drive an environment of compliance within Stryker by working with all function managers and their support staff to define expected quality standards and the roles/responsibilities in the maintenance of these standards.
• Champions a positive employee environment by promoting open communication, engagement and development of team members. Promotes a culture of trust, flexibility, teamwork and inclusiveness, ensuring all relevant Quality functions (e.g. Shared Services Quality, Supplier Quality) are included in decision making processes as part of continuous improvement, problem solving and projects.
• Selects competent talent and supports the development of their future potential. Ensures effective training and performance management of the teams.
• Ensures the site(s) maintains continued certification to all regulatory bodies. Plays a lead role in all internal and external audit programmes such as Corporate, notified body & FDA audits.
• Ensures effective management and control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Manages product & patient risk.
• Develop a quality planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management.
• Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators, and takes timely action to address adverse trends and deviations. Continuously monitors and partakes in global forums to assess opportunities for improvement.
• Foster strong collaboration on a global scale by participating in and leading cross functional and global process improvement initiatives.
• Has a strategic view in identifying global alignment and developing strategies for best in class practices and benchmark against industry leads and regulatory requirements for the Quality function.

What you will need:

• Bachelor’s Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage (Level 8).
• Minimum of 8+ years experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
• Minimum of 4 years experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team.
• Demonstrated leadership ability to develop and implement organisation and functional strategy.  Initiates, sponsors and implements change with a demonstrated track record in QA Improvement.

  

 

Ireland Pay Ranges:

• Ireland: €76,000 - €126,000 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.

  

 

Travel Percentage: 10%