Overview
Quality System Manager Jobs in Clara, County Offaly, Ireland at innov8 LABS
Title: Quality System Manager
Company: innov8 LABS
Location: Clara, County Offaly, Ireland
At Innov8 Labs, we’re proud to be a GMP-accredited health and beauty manufacturing company, based in Clara, Co. Offaly. We specialise in formulating products that people believe in across various categories such as cosmetics, skincare, oral care, sunless tan, and cosmeceuticals. Our commitment to science-first innovation drives our full-service manufacturing, contract manufacturing, private label, and packaging services. With our unparalleled expertise, deep industry insights, and diverse product offerings, we proudly partner with emerging, as well as established brands and retailers, at every stage of growth. To support our continued growth we are recruiting a Quality Manager
The Quality Manager is the responsible Person for Quality Systems and Regulatory Affairs Management. This role is crucial for ensuring that our quality management system meets regulatory standards and that our products are compliant with applicable laws and regulations.
Key Responsibilities:
Quality Management Systems:
Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485, ISO 22716, and other relevant standards.
Oversee internal and external audits, ensuring timely resolution of non-conformities and implementation of corrective actions.
Manage documentation related to quality assurance, including SOPs, work instructions, and quality records.
Regulatory Affairs:
Ensure compliance with EU Medical Device Regulation (MDR 2017/745), and the EU Cosmetic Regulation (EC 1223/2009).
Act as the Person Responsible for Regulatory Compliance (PRRC), ensuring product safety and regulatory adherence.
Prepare and submit regulatory submissions (e.g., CE Marking, FDA submissions) and maintain up-to-date knowledge of regulations.
Liaise with regulatory bodies and represent the company in regulatory inspections and audits.
Monitor changes in regulatory requirements and communicate implications to the relevant stakeholders.
Training and Development:
Provide training and guidance on quality and regulatory requirements to staff at all levels.
Foster a culture of quality awareness and compliance throughout the organization.
Continuous Improvement:
Lead initiatives for continuous improvement in quality processes and systems.
Analyse quality data to identify trends and opportunities for enhancement.
Qualifications:
Bachelor’s degree in a relevant field (e.g., Engineering, Life Sciences, Quality Assurance).
Proven experience in quality systems and regulatory affairs within the medical device and /or cosmetic industry.
In-depth knowledge of ISO 13485, ISO 22716, FDA regulations, and European Medical Device and Cosmetic Regulations.
Strong analytical, problem-solving, and decision-making skills.
Excellent communication and interpersonal skills, with the ability to work collaboratively across teams.
Strong communication and leadership skills.
Ability to work in a fast-paced environment.
Excellent problem-solving skills and attention to detail.
Willing to live the values and behaviours of Innov8LABS
Our Values
At Innov8LABS our values inform everything we do
We Put People First
We Challenge the Status Quo
We Strive for Excellence
We Act with Integrity
We Take Responsibility
We are Solutions Driven
If our values resonate and you want to grow your career with a growing company, we want to hear from you.
