Manufacturing Operations Specialist

4 days ago

Cork, Cork, Ireland beBeeManufacturing Full time €42,100 - €75,100
Job Description

We are seeking a skilled professional to lead our manufacturing operations and ensure the highest quality standards are met.

The ideal candidate will have a strong understanding of operational processes, excellent analytical skills, and be able to communicate effectively with both internal and external stakeholders.

Main Responsibilities:

  • Ensure adherence to Good Manufacturing Practices (GMPs) and system safety protocols.
  • Participate in Failure Mode Effects Analysis (FMEA), Control Plan, Standard Operating Procedure (SOP) and Production Part Approval Process (PPAP) generation associated with product transfers and scale-ups.
  • Support capital acquisition activities from specifying equipment, contract negotiation, installation, and validation.
  • Provide training for manufacturing team members.
  • Interface with Materials Science, Design, and Quality Assurance departments to provide customers with a quality product in a timely manner.
  • Validate, appraise, and support coating suppliers, machining suppliers, and raw material suppliers (e.g., Forgings, titanium).
  • Communicate and participate in system and process troubleshooting with support team members and external agents.
  • Lead and participate in cross-functional and cross-divisional process improvement initiatives.
  • Provide engineering support for new product and new process introduction, ensuring all activities are completed and documented in accordance with Stryker New Product Development Process.
  • Process validation for products and processes; VP, IQ, OQ, PQ, and associated documentation.
  • Conduct Gauge R&R studies for products and new processes.
  • Carry out structured problem-solving and application and development of statistical tools for continuous improvement projects.
  • Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.

Requirements

  • A degree in Engineering, Science, or related discipline or equivalent technical experience.
  • 0-2 years' experience in an Engineering role, ideally production, R&D, biomedical.
  • Business understanding of operations and their impacts essential.
  • A high level of PC and analytical skills required.
  • Flexibility essential.
  • Strong communication skills with both internal and external stakeholders.
  • A self-starter with demonstrated efficient work methods, analytical, and problem-solving skills and ability to handle multiple tasks in a fast-paced environment.
  • The individual should enjoy working in a dynamic and results-motivated team environment.
  • Experience in an FDA-regulated or regulated industry is beneficial.
  • Experience in a Six Sigma and Lean Manufacturing environment with proven improvement results is beneficial.
  • Green or Black Belt Six Sigma qualifications are beneficial.

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