Snr Principal Quality Systems Engineer
Our client a medical device company in Galway are currently looking to recruit a Snr Principal Systems Quality Engineer for a 12-month contract.
Responsibilities may include the following and other duties may be assigned. Services Provision of quality system services relating to the following quality system elements:
- Purchasing and Supplier Controls quality system procedures and processes.
- Risk Management processes and criteria
- Supplier Selection and Approval
- Quality Agreements
- Performance measurement and feedback
- Supplier CAPA
- Product Qualification procedures
- Critical review of quality records
- Training materials
- Training materials for delivery to Suppliers
- Other Quality System elements as applicable to specific Client projects
- Liaise and work with Client’s employees/contractors to complete Client project activities and deliverables, taking the lead to drive pertinent deliverables as applicable to project undertakings.
- Operate with a high level of discretion, flexibility and professional judgment as to how the work is performed and results achieved.
- Ensure compliance with Medical Device regulatory compliance requirements:
- Proposed solutions to address gaps in quality system procedures /processes
- New and updated quality system procedure drafts
- Template/Form design and creation
- Risk criteria and tools
- Redlined documents
- PowerPoint training slides
- Other deliverables as may be applicable to specific Client projects
- Location for performance of the Services Unless otherwise requested by Client, Services shall be provided from Contractors registered place of business or office.
- Meetings Upon request by Client, attend meetings remotely or in person to plan, execute and review progress and performance in relation to the Services.
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Coordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
The Ideal Candidate:
- Requires a University Degree
- minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
- Requires mastery of a speciality area and full knowledge of industry practices, typically obtained through advanced education combined with experience.