Arrotek Medical is a medical device engineering company offering a range of development and manufacturing services from initial design assessment, through to the provision of sterile finished product for the European and US medical device market. We strive to provide employees the opportunity to work in a competitive, growing and dynamic environment, for career development and employee wellness through providing a competitive employee package. For further information on Arrotek Medical, visit http://www.arrotek.com https://www.linkedin.com/company/arrotek-medical-ltd/.
We are currently recruiting for the position of Operations Manager.
Job Summary
The Operations Manager is responsible for overseeing and optimizing end-to-end manufacturing operations within a medical device production environment. This role ensures that products are manufactured safely, efficiently, on time, and in full compliance with applicable regulatory standards, including ISO 13485, FDA QSR (21 CFR Part 820), and other global quality and regulatory requirements. The Operations Manager leads cross-functional teams to drive operational excellence, quality, and continuous improvement.
You will have direct responsibility for the manufacturing engineering, supply chain/planning, operations, facility and health and safety areas of the business.
You will coordinate closely with Quality/Regulatory, Design Engineering, HR, Sales and Finance.
Key Responsibilities
Operations & Production Management
- Oversee daily manufacturing operations, including production planning, scheduling, and capacity management.
- Ensure production targets are met while maintaining high quality and regulatory compliance.
- Manage materials, equipment, and labour to optimize efficiency and minimize waste.
- Manage Budgets, financial planning and resource allocation within your department.
Quality & Regulatory Compliance
- Ensure compliance with ISO 13485, FDA QSR, GMP, and applicable international regulations.
- Support internal and external audits, inspections, and regulatory submissions.
- Ensure adherence to standard operating procedures (SOPs), work instructions, and validation requirements.
- Drive corrective and preventive actions (CAPA) related to manufacturing operations.
Leadership & Team Management
- Lead, coach, and develop the operations staff.
- Foster a culture of quality, safety, accountability, and continuous improvement.
- Conduct performance evaluations and identify training needs.
- Ensure adequate staffing and skills coverage across shifts.
Continuous Improvement & Cost Control
- Implement Lean manufacturing, Six Sigma, or other continuous improvement methodologies.
- Analyze operational KPIs such as yield, throughput, OEE, and cost per unit.
- Identify opportunities to reduce costs, improve productivity, and enhance process reliability.
- Lead root cause analysis and process optimization initiatives.
Safety & Risk Management
- Ensure compliance with workplace health, safety, and environmental regulations.
- Promote a strong safety culture.
Other such duties as may be assigned from time to time by their Manager.
Person Specification:
Candidates likely to be called for interview will be essential to have the following
- At least 3 years in a similar position.
- Strong understanding of medical device manufacturing processes and regulations.
- A Degree in Business, Operations or related field.
- Proven leadership and people management skills.
- Strong attention to detail, ensuring high levels of quality at all times.
- Strong analytical and data-driven mindset.
- Effective communication and cross-functional collaboration skills.
- Strong strategic and problem-solving experience with the ability to multitask and prioritise workload.
- Experience in a fast paced, dynamic role.
Position Details
This is a full-time position on a Permanent contract with a view to starting as soon as possible.
Applications:
Interested applicants should submit their up to date CV and Cover Letter to [email protected]. All applications will be treated in strict confidence.
Arrotek Medical is an equal opportunities employer.
