Quality Management System (QMS) Team Lead

About Aerogen:
Headquartered in the vibrant city of Galway Ireland with offices around the world Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America collectively our employees make a difference to patients lives every day having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate challenge and test not only in relation to our products but every facet of how we work. We lead the way finding innovative solutions to even the most complex problems all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow our core culture of We Care universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to#discoverbetter.

What is the role
As a Quality Management System (QMS) Team Lead you will be responsible for developing and maintaining our organizations Quality Management System (QMS). Your management of the system will ensure Aerogens products and services meet the relevant standards including EN ISO13485 FDA QSR and MDSAP. You will also lead System Engineers and Data Systems Analysts to support the organisation from a compliance and audit perspective.

What are the key responsibilities
Lead and oversee the Quality Systems team ensuring effective coordination communication and collaboration.
Ensure team is adequately resourced manage recruitment of key talent (where necessary) with focus on retention of talent through engagement activities action planning and meaningful work.
Mentor coach and guide employees during their employment providing holistic performance feedback prepare individual development plans incorporating stretch & development opportunities to enable employees to progress their careers at Aerogen.
Take a leading role in the further implementation of eQMS software in collaboration with Project Manager and SMEs across Aerogen.
Continue to develop and maintain the current Quality Management System (QMS) in compliance with the ISO 13485 standard.
Develop and maintain quality risk management policies processes and procedures to support QMS implementation and improvement.
Undertake quality risk assessments and maintain and update the Departments Risk Register.
Facilitate external certification assessment for ISO 13485 by organizing and overseeing the certification process including hosting audits by external bodies for certification purposes and by industry customers.
Lead preparation and coordination activities for external audits and liaise as required with SMEs to ensure audits are conducted in an efficient manner.
Identify and implement opportunities for improvement within the quality system processes procedures and practices in collaboration with the appropriate internal stakeholders.
Coordinate the internal audit process and audit team to ensure that all audits are completed in a thorough and timely manner. Conduct quality audits and assessments to ensure compliance with QMS requirements and identify areas for improvement.
Manage documentation control process related to the QMS including change management for policies procedures and records.
Drive continuous improvement efforts and monitor and analyse quality performance metrics to identify trends and areas for improvement.
Collaborate with cross-functional teams to implement quality improvement initiatives and resolve quality issues.
Provide training to employees on QMS requirements and quality standards.
Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.
Coordinate preparation compilation and presentation of Management Review content.
Promote the awareness of regulatory and customer requirements throughout the organization and ensure team members gather key data metrics for quality objectives and feedback at Management Review.
Ensure team members complete quality systems induction training for new hires and ongoing training related to compliance.

What education and experience are required
Bachelor degree in Engineering Science Quality Management or a related field.
Certification in Quality Management is preferred. (e.g. ISO 13485 Lead Auditor MSc in Quality Systems Management
Certified in ISO 13485 and MDSAP
At least 7 years experience working in a regulated medical device or pharmaceutical company.
Experience in people management with a large team.
Experience with using eQMS software. Past participation in an eQMS implementation project would be advantageous.
Past experience of implementing or evolving a QMS would be distinct advantage

What key skills will make you great at the role
Experienced Quality Leader in Medical Device industry
Proven experience in maintaining and evolving a Quality Management System
Strong understanding of ISO requirements and quality management principles.
Excellent analytical and problem-solving skills.
Strong communication influencing and interpersonal skills.
Comfort with digital transformation
Embrace change and encourage process and system innovation.
Ability to work independently and collaboratively in a team environment.
3 years of people leadership experience in a growing company
Strong emotional intelligence and ability to lead coach and develop employees

What is it like to work at Aerogen
Our purpose is to transform patient lives and our ethos is to#discoverbetter.This also translates to how we look after our people. We want talented passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages and we are here to support our global team with a range of financial and non-financial rewards and benefits. Theres something for everyone! Here is an idea of what we offer:
Excellent medical care.
Bonus & Pension.
Long-Term Incentive Plan.
Aerogen Connect our employee led programme which supports our global teams to unite and have fun.
We pledge 1% of profits and time to charities and organisations.

Visit our careers website for more information about life at Aerogen.

Aerogen is committed to promoting diversity inclusion and equality in the workplace. If you have difficulty using our application process please contact us via email at emailprotected. Please provide your name and preferred contact method.