Senior Quality Engineer Role Overview
The primary function of this role is to provide technical leadership within a team to support various functions, including Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development, and Engineering Sustaining teams.
This includes providing support to process validation, change requests, non-conforming product issues, corrective and preventive action programs, design and process FMEA, risk assessment, and associated quality system documentation.
Reporting directly to the Team Lead, this role ensures that all assigned projects are managed in a structured fashion and completed in compliance with relevant procedures.
Responsibilities
* Drive all assigned projects and ensure timely completion of project milestones.
* Manage and drive project activities to ensure effective collaboration between teams.
* Represent the team at key review meetings and build effective relationships with other functions.
* Lead in the area of FDA, QSR, and ISO13485 requirements, promoting awareness of best industry practice and making informed decisions daily.
Requirements
* Demonstrated proven experience and proficiency across functional areas:
o Design
o Process
o Risk Management
o Software Validation
o Supplier Quality
o CAPA
o Non-Conformances
o Customer Complaints
o Sterilization
o Statistics
o Facilities/Environment
o Microbiology/Biocompatibility
o 6 Sigma/Lean/Continuous Improvement
* Support of internal audit, supplier audit, and regulatory audit programmes.
* Trending and analysis of key quality metrics.
* Responsible for the assessment of risk throughout key processes and systems.
* Provide mentoring to team members to ensure effective completion of activities.
Qualifications
* A third-level qualification in Science, Engineering, or a relevant technical discipline.
* Proven knowledge and experience (minimum 4 years) of working with ISO13485, ISO14971, EU Medical Device Regulation, and FDA QSR.
* Excellent communication and interpersonal skills.
* Proven track record of pursuing continuous self-improvement.
* Good working knowledge of Microsoft Office.
* Proven problem-solving skills.
* Willingsness to travel on company business.
To be considered for this role, please complete the application process on our careers page.