Job description

I'm delighted to be working with this award winning Medical Device client based in Limerick who have opened an Associate Director of Quality role. This role comes with great opportunity for growth and a strong salary and benefits package. If you are interested, please do not hesitate to apply below, or email me directly at julieannfitzpatrick@sigmar.ie for more information. 

As Associate Director of Quality, you will work closely with them to discover paths to introduce innovative solutions to improve device quality and quality assurance, uncover new opportunities and formulate strategies to enhance quality efficiencies.

You will be leading a rapidly growing team, providing ample room for demonstrating leadership and management acumen. Our ideal candidate will possess a robust background in orthopedics, with a demonstrated proficiency in Quality Assurance and Quality Control, lean principles, process enhancements, and exemplary manufacturing practices. Proven success in meeting sales objectives and KPIs, combined with strong leadership, motivational, and interpersonal skills are essential. As a key part of the management team, you will work alongside the COO, CFO and CEO. A competitive salary and benefits package await the right candidate.

KEY RESPONSIBILITIES:

• Lead, inspire and grow a dynamic team.
• Lead the site’s Quality team in the management of the plant’s, Quality control, Quality Assurance, and product disposition processes.
• Maintenance and ongoing improvement of the site QMS.
• Manage and report quality metrics in relation to site performance.
• Provide quality leadership during regulatory agency inspections, internal audits, and Business Unit inspections,.
• Support technical transfers programs, supplier selection programs, and commercial manufacturing activities.
• Review validation documents, deviations, and change controls and escalate any potential compliance gaps.
• Play a lead role among management peers in sustaining a strong Quality culture for the site;
• Implement the Quality Strategy in line with the Quality Management System;
• Leverage your existing professional network and prior successes.
• Utilize our award-winning R&D and innovation techniques to position yourself as a thought leader.
• Collaborate with a talented team to drive business growth.
• Enhance your solution selling skills in a technologically advanced and evolving environment.
• Exercise autonomy in decision-making and problem-solving.
• Contribute to team development and camaraderie.

WHAT WE EXPECT FROM YOU:

• 3-5 years of experience in a position in Quality Management in the Medical Device sector.
• Experience in a fast-paced environment.
• Understanding of market regulatory requirements.
• Degree/Post Graduate qualification in Engineering, Business Studies, Science, or a related field (Post Graduate qualification preferred but not essential).
• Ability to foster long-term relationships.
• Understand key business drivers for the industry with previous experience in Medical Device Regulations, Quality, and a proven track record in managing multiple projects;
• Demonstrate high technical ability and attention to detail to do the job at a high level of accomplishment.

CORE COMPETENCIES:

• Ability to review/approve process and equipment validations.
• Ability to manage multiple NCs and CAPAs.
• Effective communication and collaboration skills.
• Commercial acumen and quick follow-up capabilities.
• Resilience in both personal and professional capacities.
• Proactive lead generation.
• Self-initiative, clarity in deliverables, and adherence to company and client policies.
• Consistency and commitment to deliverables.