Senior Engineer, Change Analyst

Contract: Initial 23 month (FTC)

Location: Anngrove, Carrigtwohill

On-Site Position

Who we want:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

What you will do:

The Senior Engineer, Change Analyst will provide technical leadership and direction in changes. Responsible for the oversight & assessment of changes to the quality management system. Will oversee and ensure that changes to quality management system processes and procedures are compliant, effective and pose no risk to the quality of the product/processes.

Will work within the QMS team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:

• Execute and/or Participate in the Change Control review forums and in multi-site forums.
• Lead, facilitate, and mentor teams through all stages of the change control process.
• Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes.
• Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness
• Liaise with Change Requester and SMEs during all stages of the Change Control process.
• Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight.
• Monitoring completion of post release tasks to ensure completion in a timely manner.
• Support and lead initiatives for continuous improvement.
• Participate in cross-plant and corporate project teams in areas of change control.
• Manage Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums.
• Support in training needs related to the change control process
• Support in the preparation, participate and follow up to Stryker Internal, Corporate and third-party compliance audits.

Qualification Knowledge Skills:

•  An Honours Bachelor’s degree (Level 8)
• 2-3 years’ relevant experience in a quality/ QA or technical position
• Previous experience in industry desirable
• Understanding of Med Device concepts desirable.
• Familiarity with ISO 13485, GDP, GMP concept desirable.
• Excellent communication skills and attention to detail.
• Have a good understanding of engineering and quality concepts / theories.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
• Must be willing to work as part of a multi-site team, with some travel required.
• Knowledge of Risk Based and statistical concepts desirable.
• Problem solving and analytical skills.
• Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
• Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
• Accepts change openly and adopts a continuous improvement orientation to the role
• Excellent English (both oral and written)

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