The Engineering Supervisor will be responsible for the supervision of Tullamore Project Engineering group on plant projects and plant initiatives to improve process capabilities. The role will incorporate site validation activities as the site Validation Subject Matter Expert supporting process and projects activities.
Essential Functions and Responsibilities
- Leading a group of Project Engineers in the execution of corporate projects in accordance to sites Project Management Process meeting scope, cost, and time requirements.
- Managing the site's project portfolio reporting out to the Site Management team.
- Accountable for the disciplined implementation of Project Management tools and best practices.
- Site Validation SME with specific expertise and responsibilities for validations to include defining validation policy, ownership, and administration of site validation procedure, verification of conformance to policy, resolving validation disputes, and non-conformance resolution.
- Manage, mentor, and develop Project Engineers and Validation Team to meeting site requirements.
- Key stakeholder providing validation input on project planning.
- Support the various engineering groups in process characterization and optimization.
- Trending and analysis of site validations to meet regulatory, compliance and performance requirements.
- Managing the site project and validation performance KPI's, MVP and project portfolio.
- Support site Process Engineers in validation activities.
- Drive continuous improvement within various Engineering and Validation practices.
- Present and defend validation approaches and results to all external and corporate auditors.
- Actively participate in and support company and plant wide initiatives including six-sigma, lean, safety and cost reduction.
- Assist in the maintenance of a safe company culture by working within the company's health and safety guidelines at all times and reporting any equipment or process problems in line with plant escalation procedures
- Identify continuous improvements opportunities where possible and take part in improvement projects as assigned.
- Carry out additional duties that may be assigned to you.
Qualifications & experience
- A degree in Engineering / Technical discipline or equivalent experience.
- A minimum of 8 years' experience working in the medical device industry with focus on project management, validation activities and process capability
- People management experience
- PMP or Prince2 qualification
- Audit facing experience with FDA and Notified Bodies essential
- Proficient in Minitab and data analysis
- A Six-Sigma certification is desirable but not essential
SKILLS & COMPETENCIES REQUIRED
- Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), FDA, cGMP, and Risk Management (ISO 14971)
- Experience in a supervisory or leadership role with people management responsibility
- Ability to work with cross-functional teams, including production, quality, engineering and materials.
- Experience working with moulding and extrusion processes and with automated assembly processes is desirable.
- Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance.
- Organised and resourceful with excellent attention to detail and ability to get the job done
- Clear written and verbal communication skills
- Energy and self-motivation.
- The ability to focus on problem resolution in the plant.
- The ability to take responsibility for their own professional development and implement new approaches to doing things. Focused on simplicity of implementation.
- An excellent record of attendance and time keeping
- Commitment to work within the ethos of the company Mission, Medical Devices & Supplies Guide to Compliance and Quality Manufacturing and The Standards of Business Conduct
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.