Our client a medical device company in Galway is looking to hire a Senior Quality Assurance Lead Engineer for their site.
The position of Senior Quality Assurance Lead Engineer requires an experienced and proven candidate with a background in Quality Control, Quality Assurance and Regulatory compliance of Medical Devices. In this position you’ll be supervising the Quality Control Inspection team.
The successful candidate will work as part of a team to maintain high quality/performance standards across the company.
Reporting to the Director QA/RA, the position will be challenging and will require an ability to work autonomously.
Responsibility and Authority
- Provide Leadership / Direction and Support to the QC Inspection team including:
- Maintenance of fully compliant documents and procedures
- Management of training/development needs
- Co-ordination of QC inspection schedules aligned to support and deliver Quality/Manufacturing/Design Services -NPI/ Customer deadlines
- Management of environmental monitoring activities, Endotoxin (LAL) and Product Bioburden sampling program
- Management of QC Inspection record review / release, including final product release
- Complete customer and supplier notification change assessments and appropriate follow on actions
- Co-ordination & Review of Key Performance Indicator data for presentation to Management
- Co-ordinate Customer Complaint processing (investigations and customer response)
- Co-ordinate Internal audits of Clean Room (Line audits)
- Collaborate with the Project teams to facilitate the successful execution of the Design Services process and Commercialization of new products.
- Provide expertise in the areas of Quality Assurance, Design Controls, Risk Management, Statistical Techniques, and Regulatory Compliance and Submissions
- Lead and Support Design Services engineering activities (including but not limited to)
- New product introductions
- Development and approval of new product documentation.
- Qualification of new suppliers/ requalification of existing suppliers
- dFMEA, Risk management activities
- Provide expertise for new product introduction / product development / process changes with respect to
- Acceptance criteria development
- Test method development/validation activities
- Product / process validation protocol development and execution (IQ, OQ, PQ)
- pFMEA, Risk management activities
- Material / Product testing requirements (e.g. ISO10993)
- Ensure that new medical device product development / new product introduction and changes to existing products are conducted in compliance with global regulations and internal procedures.
- Review Design History Files and Technical Files for conformance to applicable requirements.
- Contribute to process improvement efforts by developing and updating procedures and work instructions.
- Develop and maintain documentation in compliance with FDA, ISO, MDD/MDR requirements
- Provide on-going support to manufacturing site(s) for commercially available products
- Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations
- Initiate / Support implementation of effective Corrective / Preventive Actions
- Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc.
- Act as the QA representative for Supplier Quality management activities
- Represent QA as part of the Material Review Board
- Perform Internal and Supplier Audits
- Support Notified Body / Regulatory Agency / Customer Audits
- Collate and trend Key performance indicator data
- Actively participate in Management Review & Compliance meetings
- Act as delegate for Quality Manager when required
- Perform additional duties as required by the role and management
- Minimum degree in Quality Engineering, Manufacturing engineering, Life science or related field.
- Minimum of 5 yrs. experience at Senior Engineer level within the Medical Device Industry including at least 2yrs. proven People management experience.
- Proven record of handling multiple tasks simultaneously and ability to manage project timelines
- Proven record of policy and procedure development
- Can demonstrate understanding and application of quality philosophies, principles, systems, methods, tools, and standards
- Must be highly motivated with excellent communication skills and proven ability to work effectively as part of a team and interact professionally with all organizational levels
- Act as a mentor to less experienced colleagues
- Quality Certification and Lead Auditor Certification is a plus
- Supplier Quality engineering experience is a plus
- Sterilization / Microbiology experience is a plus
- Ability to travel is a requirement
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