Europlaz Technologies is a leading contract medical device manufacturer

Europlaz Technologies leading contract medical device manufacturer

Production Manager - Single Stream

FULL TIME, PERMANENT ROLE 

Main purpose of the job

The role involves being the project lead and point of contact for the successful manufacture of a new medical device product within a cleanroom.  the right candidate will have experience of managing a product with a significant and fast paced ramp up to high volume manufacture.  

This role would suit an enthusiastic all rounder who has excellent experience in Production and project management within the medical device industry. 

We are looking for an organized person who can handle multiple tasks and developments while always ensuring good communication and attention to detail. 

The role will include managing production in a cost-effective manner and ensuring efficiency in all processes including materials into manufacturing, capacity and resource planning, dispatch and customer service within the approved Europlaz processes, policies and procedures.

Key Roles and Responsibilities

Production and Project Management 

  • Production representative in the development process, acting as internal customer for engineering department 
  • Manage all aspects of production for this product stream to ensure increases in volume are planned and can be achieved smoothly 
  • Work with engineering department on readiness for production including completing the relevant validations in a timely manner – 
  • Ensuring availability of production capability
  • Work with the quality team to Draft and approve quality documentation to meet Customer requirements i.e. Quality Specification Sheets (QSS), CAPA’s, Defect Library 
  • Implement and comply with agreed quality systems.
  • Interface on an ongoing basis with customers to ensure requirements/concerns and complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
  • Liaise with Purchasing Manager and goods in to ensure on time delivery and correct quality 
  • Effective planning of the manufacturing schedule for product in conjunction with Europlaz planning team
  • As required, oversee and performs inspections and applicable tests for assigned products and processes to ensure accurate requirement implementation and fulfilment of contractual requirements.

Leadership 

  • Lead the team to achieve the manufacturing objectives and KPIs including OEE
  • Monitor and control the allocation and use of resources
  • To support, mentor and train the team to maximize the potential of every member of the team and the team collectively.
  • Maintain healthy, safe and productive working conditions.
  • Where appropriate, to propose and undertake continuous improvement activities
  • Regularly provide proactive feedback to the customer 
  • Regularly report on the performance of the product stream 
  • Support during external audits and help complete internal audits on the specific product and process  
  • To lead by example and ensure best practice throughout and at all times

Role development 

  • Ensures that project and/or process control documentation is compliant with requirements 
  • Ensuring all systems are followed throughout, records are properly maintained, and documentation fully completed
  • Ensure all risk management documentation is in line with ISO standards 

Experience, Qualifications and Education Requirements

Essential 

  • Degree qualified in a manufacturing or engineering discipline And/or
  • Previous relevant management Experience.

Desirable 

  • Experience in medical device quality assurance with a background of working in a regulated manufacturing environment.
  • Engineering Experience 
  • Excellent planning skills 
  • Experienced in Process Validation to Medical Device Regulatory requirements IQ, OQ, PQ 
  • Knowledge of medical device regulatory requirements 
  • Ability to develop and write protocols, validation reports, engineering reports, etc.

Preferred Skills

  • Capable of multi-tasking with enough ease to meet multiple priorities and deadlines
  • Effective problem solver 
  • Has experience of working on own initiative 
  • Has empathy in dealing with staff situations, mature outlook and balanced perspective
  • Makes efficient use of resources and control costs
  • Strong leader with excellent influencing skills
  • Analytical with excellent skills in analyzing information and data and strong at presenting complex issues clearly
  • Enthusiastic, engaging open style, setting examples for team
  • Creates effective working relationships with internal and external customers
  • Is aware of own strengths and weaknesses
  • Experienced practitioner in all aspects of IT, e.g., MRP systems, MS office

 

To apply please send a CV and any supporting information to HR Manager Laura Shattock. 

laura.shattock@europlaz.co.uk