Operations Manager – Medical Device Manufacturing
Sligo | Permanent | On-site
We are partnering exclusively with Arrotek Medical, a fast-growing medical device engineering and manufacturing company, to recruit an experienced Operations Manager for their Sligo site.
Arrotek Medical provides end-to-end medical device services, from initial design and development through to sterile finished product manufacturing for the European and US medical device markets. The company offers a dynamic, quality-driven environment with strong opportunities for career development, leadership growth, and employee wellbeing, supported by a competitive benefits package.
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The Role
As Operations Manager, you will have full responsibility for end-to-end manufacturing operations within a highly regulated medical device environment. You will ensure products are manufactured safely, efficiently, on time, and in full compliance with regulatory and quality standards including ISO 13485, FDA QSR (21 CFR Part 820), GMP, and other global regulations.
This is a senior leadership role with responsibility for manufacturing engineering, supply chain and planning, production operations, facilities, and health & safety, working closely with Quality & Regulatory, Design Engineering, HR, Sales, and Finance to drive operational excellence and continuous improvement.
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Key Responsibilities
Operations & Production Management
- Lead daily manufacturing operations, including production planning, scheduling, and capacity management
- Deliver production targets while maintaining high quality and regulatory compliance
- Optimise use of materials, equipment, and labour to improve efficiency and reduce waste
- Own departmental budgets, financial planning, and resource allocation
Quality & Regulatory Compliance
- Ensure full compliance with ISO 13485, FDA QSR, GMP, and international regulations
- Support internal and external audits, inspections, and regulatory activities
- Ensure adherence to SOPs, work instructions, validations, and quality systems
- Drive CAPA investigations related to manufacturing and operational issues
Leadership & Team Management
- Lead, coach, and develop a multidisciplinary operations team
- Foster a culture of quality, safety, accountability, and continuous improvement
- Conduct performance reviews and identify training and development needs
- Ensure appropriate staffing levels and skills coverage across shifts
Continuous Improvement & Cost Control
- Implement Lean Manufacturing, Six Sigma, and continuous improvement initiatives
- Track and analyse KPIs such as yield, throughput, OEE, and cost per unit
- Identify and deliver cost reduction, productivity, and process optimisation opportunities
- Lead root cause analysis and process improvement projects
Health, Safety & Risk Management
- Ensure compliance with health, safety, and environmental regulations
- Promote and embed a strong safety-first culture across operations
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Candidate Profile
To be successful in this role, you will bring:
- Minimum 3 years’ experience in a similar Operations / Manufacturing Management role
- Strong knowledge of medical device manufacturing processes and regulatory requirements
- A degree in Business, Operations, Engineering, or a related discipline
- Proven people leadership and team management experience
- A detail-oriented, quality-focused mindset
- Strong analytical, data-driven decision-making skills
- Excellent communication and cross-functional collaboration ability
- Demonstrated experience managing multiple priorities in a fast-paced environment
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Why Join Arrotek Medical?
- Growing, innovative medical device manufacturing company
- Exposure to EU and US regulated markets
- Leadership role with real impact and visibility
- Competitive salary and benefits package
- Strong focus on career progression and employee wellbeing
For more details on this role, feel free to reach out to Davin Ferguson at davin.ferguson@coillinsmcnicholas.ie
Kindly note that, given the expected high volume of applications, we can only respond to candidates whose qualifications closely match the specific requirements of the role. We genuinely value your interest in this opportunity and thank you for your understanding.
