The Quality Engineer will provide QA/QC technical and compliance expertise as part of teams tasked with establishing and assuring system and product quality objectives. The Quality Engineer will assure compliance to applicable regulations and company Quality Standards and perform quality activities such as data analysis, QMS audits, procedure development, product release, documentation review and implementation of changes to controlled documents.
*Candidates must be legally entitled to work in Ireland. Sponsorship will not be provided.
- Provides QA technical and compliance support for products and manufacturing related to suppliers, corrective and preventive actions, product/process improvements and training.
- Monitors compliance to company policies, procedures and applicable regulatory requirements, identifying and implementing process and system improvements as applicable.
- Applies thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Plans, executes, reports and follows-up on quality system audits (supplier and internal)
- Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations.
- Makes decisions that are aligned with management objectives regarding work processes, plans and schedules to achieve quality objectives.
- Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
- Resolves project issues by working with team members, management, suppliers, and others as appropriate.
- Assists department and project leaders in developing and reporting appropriate performance and quality metrics.
- Reviews and approves manufacturing, test and validation data/records to establish conformance to technical specifications and performance standards for existing, new or modified products and processes.
- Provides technical quality guidance to team members, technician and inspection staff.
- Responsible for communicating business related issues or opportunities to next management level
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Bachelor's Degree in Engineering, Science or related technical field preferred.
- 2 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. Auditor certification from an industry recognized organization is beneficial.
- Experience in the preparation for notified body and FDA inspections advantageous.
- Experience in the QA activities associated with a manufacturing environment including project management skills and leadership ability.
- Proficient in basic IT skills relevant to the applications related to the tasks assigned, i.e. the use of word processors and similar windows-based applications, e.g. MS Office products.
- Demonstrated abilities on achieving results within assigned deadlines with an ability to handle multiple tasks and operate in a fast-paced environment.
- Ability to work cooperatively with co-workers and the public.
- Demonstrates an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to production, project and team environments.
- Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the
- European Medical Device Directive/Regulation. Knowledge of other applicable medical device regulations, e.g. Brazilian, Canadian, Australian, Japanese, Korean, etc., advantageous.
- Excellent interpersonal skills and ability to work with people to achieve results.
- Excellent written and communication skills, fluency in English.
- Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making.
- Motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
- Certified QMS Auditor advantageous.
For an immediate interview please forward your CV using the apply button
Or call Megan Warr on 091507515 for a confidential conversation
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