PhillipsMedisize Hiring For Site Quality Lead at Sligo, County Sligo Full Time

Your Job

The Quality Site Lead has responsibility for ensuring that the integrity of the local Quality Management System is maintained when changes to the QMS are planned and implemented. This includes providing cross functional support to the maintenance of the local QMS to ensure compliance to the Divisional QMS, including local process

Our Team

The Quality Site Lead will act as the management representative with regard to ISO 13485 standard and report out on the performance of the Quality Management System to Management with executive responsibility at the management review meetings. This role is located in Sligo, Ireland

What You Will Do

Facilitate the communication of Divisional QMS updates within the site to enable functions to review and progress any site-specific updates within documented local process.

Support the maintenance of the local Quality Management System to compliment compliance to the Divisional QMS.

Responsibility and authority for ensuring that processes needed for the Quality Management System are established, implemented and maintained.

Reports on the performance of the Quality Management System at the management review meetings.

Coordination of customer and third-party audits.

Ensure the latest versions of all relevant Standards and Regulations are available to ensure ongoing compliance.

Manage Complaints/ CAPA process – Quality Reporting; maintain oversight of customer and vendor complaints.

Manage and Mentor Quality Team. Motivate staff by promoting a positive environment where achievements and accountabilities are acknowledged, and open two-way communication encouraged. Provide training and coaching to Direct reports.

Support continual improvements programs.

Who You Are (Basic Qualifications)

Third level university or professional qualifications in Quality, Engineering, Science or related discipline is essential.

Strong working knowledge of all regulatory requirements, international standards and FDA requirements.

Strong auditing skills/qualifications with a comprehensive understanding of key pharmaceutical processes, validation, facility and service requirements

Thorough knowledge of Quality disciplines including Quality, Planning, Costs of Quality, Quality Monitoring, Quality Systems and Quality Statistics.

Proven past working experience as people manager; ability to foster team environment, invest in team members and peers by inclusion and listening, recognizing employees effectively, and demonstrating trust.

Ability to respond positively to change, embracing and using new practices or values to accomplish goals and solve problems. Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people.

Strong organizational skills, ability to define, delineate roles and responsibilities effectively; plan well, flexible and able to facilitate change, optimize quality and productivity as projects progress.

What Will Put You Ahead

Diagnostics/Medical Device/Pharmaceutical experience will be highly beneficial.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate’s knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.