- Reference: CJ43039yyyy
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
Senior Quality Engineer
Works cross-functionally to provide Quality expertise and guidance to project activities from New Product Introduction to Process Changes ensuring efficient and effective alignment and compliance with company policies and procedures, the corporate Quality System and regulatory requirements
- Manage, mentor and coach a high performing team of Quality Engineers & Technicians working on project based activities.
- Provide effective and responsive Quality support to project teams to meet their objectives of safety, quality & compliance, timeliness & cost.
- Communication and escalation of key Quality concerns/issues
- Work crossfunctionally to ensure all process variables and their interactions are adequately defined, failure modes in process have been identified and appropriately addressed
- Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Identification & Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
- Ensure Regulatory compliance in area of responsibility to all medical device regulatory agencies (e.g. FDA , DEKRA, BSI).
- Provide functional expertise to other support functions on quality related issues (e.g. Quality System requirements, regulatory requirements, statistical techniques, sampling principles).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. In Process monitoring, SPC, CpK analysis, sampling techniques).
- Approval of change requests for product, process and quality system changes.
- Customer complaints: Partner with Design Assurance to ensure appropriate focus on customer complaint analysis and trending through product commercialisation – taking action where required.
- Problem Solving: Lead a diverse scope and complexity of problem solving activity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Demonstrate a broad knowledge of a variety of alternatives and their impact on the business unit.
- Validation: Align with Process Development and Manufacturing Engineering to identify and define appropriate process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- Support compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
- Champion key Quality Metrics for the Quality project team CAPA, Quality Incidents, manufacturing complaints, RFT, Audit results etc. Identify and drive improvement opportunities.
- Support the implementation of Lean Manufacturing across the site, in particular in new process development areas.
- Resource Management: work with Quality management to ensure appropriate project Quality resources are in place to support the project activity. Plans and organizes project assignments and maintains project schedules.
Experience & Qualifications:
- Requires a minimum level 8 relevant Engineering / Science degree
- Excellent interpersonal and communication skills with good leadership abilities.
- Ability to work as part of a team and meet targets/goals efficiently.
- Excellent analytical and problem solving skills.
- Minimum of 4+ years experience within the medical device or pharmaceutical manufacturing industry – people management experience an advantage.
- Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email email@example.com
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