Duties / Responsibilities
- Ensuring that vendors possess the necessary skills, expertise and certification.
- Ensuring that all externally sourced parts conform to specification.
- Identifying with the vendors areas for improvement to include: increased capacity, better quality, improved reliability, more efficient manufacture and better customer service.
- Scoping out and project managing such improvement projects.
- Monitoring and statistically analyzing process data, quality and production yields.
- Monitoring and ensuring that key process indicator (KPI) targets are delivered and met.
- Be the main in-house representative of the vendor in-house and the champion for all associated improvement initiatives.
- Implementation of lean and operational excellence principles (6σ, 5S, TPM)
- Identifying new and additional vendors.
- Participating in vendor approval and surveillance audits to ensure fit for purpose.
- Leading process and components approvals at vendor sites.
- Liaise with stakeholders (colleagues & suppliers) to derive the necessary outcomes.
- Be prepared to represent such documentation in an audit by customers, revenue or regulatory authority.
- Maintain compliance with all manufacturing and quality related documentation
- Perform other assigned tasks as directed by Supervisor or Head of Function
- Meticulous attention to detail with a methodical and analytical approach with good problem solving tool skillsets
- Very strong organizational and Project Management Skills
- Knowledge of Design Verification and Process Validations, particularly as it pertains to equipment and manufacturing processes.
- Green or black belt certification an advantage.
- Knowledge of electro-mechanical components and sub-assemblies and related processes an advantage
- Excellent understanding of ISO 13485 and FDA Design and Development Processes.
- Excellent planning and communication skills.
- Ability to work effectively as part of a multi-disciplinary team is a key requirement.
- Experienced in dealing with marketing, and regulatory teams.
- Ability to lead complex problem solving and cost/capacity improvement projects with cross functional teams.
- Ability to present ideas and concepts clearly and effectively.
- Familiar and comfortable with standard medical device documentation.
- Ability to grasp and statistically analyze data to achieve desired outcomes.
- Highly motivated self-starter with an innovative mindset.
Education / Experience
- 5 years’ equivalent experience in a Medical Process Development or Manufacturing Environment
- Minimum of a primary degree in an Engineering or Technological Discipline
- Typical office environment with work also performed in Development labs and Manufacturing areas in addition to customer/supplier locations
- Some national and international travel will be required with role (up to 30%
Some of the benefits our employees enjoy:
- VHI including Dental
- On-site Free Parking
- Paid Holidays
- Sports & Social Club
- Flexi- Start Time.