Senior Quality Engineer with ISO 13485 & FDA experience required for permanent role with dynamic medical devices company designing life-saving medical devices in Galway.
You will manage both Product and Process Verification and Validation activities and lead Quality Engineering support on project activities. The role will require a high degree of flexibility to coordinate the variety of tasks as well as practical knowledge of current Project Management tools.
Hybrid working model.
Requirements:
- BE/BS Degree
- 5 years’ experience in a similar capacity in a regulated industry (i.e., FDA /ISO)
- Minimum certification to Green Belt Lean Six Sigma (or recognized equivalent qualification)
- Minimum of 3 years Supervisory / Management experience in a Medical Device /Pharmaceutical regulated industry
- Thorough understanding of ISO 13485 and FDA QSR standards
- Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry
- A thorough understanding of GMP/ISO and validation regulations
- Experience of regulatory landscape with respect to FDA, CE Marking plus other regulatory territories while not mandatory is considered beneficial
- Ability to work on own initiative
- Strong team member with the ability to identify and drive implementation of innovative quality improvements
- Ability to work within project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately
- Demonstrate and actively promote high levels of professional quality engineering
- Must have the ability to communicate effectively at all levels of the company
- Process Validation and Injection Moulding experience is desirable
- Ability to liaise with suppliers, customers, and regulatory contacts in an informed professional manner
- Good administrative/organizational ability with high level of attention to detail
- Post-graduate qualification in Quality Assurance is preferable although not mandatory
Key Responsibilities:
- Manage both Product and Process Verification and Validation activities as related to the specific scope of planned work associated with the asset / process in question
- Lead Quality Engineering support on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements, and New Product Introductions etc.
- Manage activities within the project teams ensuring that project planning is completed correctly with full evaluation and engagement from the necessary resources
- Lead investigation of quality issues should they arise during day-to-day production or within projects – work with project leaders, quality, materials, manufacturing, and suppliers to resolve issues
- Liaise with the Supplier Quality group to ensure Supplier Approval Requirements are met
- Ensuring conformance with current equipment, process and systems validation regulations
- Determine process inputs and factors for variation where process capability is required
- Partner with R&D and other cross functional teams to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges
- Provide timely and accurate reporting and management of escalations as appropriate on project activities
- Establish analysis techniques and other quality control tools within project activities as well as utilization of these to solve specific quality problems
- Overall responsibility for GMP standards and compliance within Project Teams
- Maintain compliance with ISO and FDA and all other relevant ‘in country’ Quality System regulations
- Utilization of recognized Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision
- Utilize appropriate risk management to prevent unanticipated failure modes and help improves the capability of processes
- Provide Statistic overview of all relevant activities to ensure that use of sampling plans and treatment of results adheres to best accepted statistical practice
- Ensure that all health, safety, and environmental requirements are fulfilled
- Support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary
Please send cv in confidence to emer@emtechrecruitment.ie
