Position Title: Senior Quality Engineer

Position Summary

To provide QA technical and compliance expertise as part of teams tasked with establishing and assuring system and quality objectives. Assure compliance to applicable regulations. Lead quality activities such as audits, procedure development, documentation review and define changes to controlled documents. Provide QA technical and compliance support for products and manufacturing related to suppliers, corrective and preventive actions, product/process improvements and training.

Responsibilities

• Responsible for compliance with company Policies and Procedures and applicable International Regulations
• Leads and/or facilitates compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel training).
• Monitor compliance with companies policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.
• Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
• Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to project and team environments, including contributing towards the generation of risk management file documents; Risk Management Plan, dFMECA, and associated reports.
• Represent company professionally and positively externally to agencies, vendors, and regulators.
• Team member for the implementation of QMS electronic systems.
• System Administrator for Greenlight Guru.
• Other responsibilities will include (but are not limited to) the following:
• • 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 in order to achieve quality objectives.
• • Resolves project issues by working with team members, suppliers, and others as appropriate.
• • Provides technical quality guidance to the team as required.

Essential Skills / Experience

• 5 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. Auditor certification from an industry recognized organization is beneficial.
• Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016
• Experience in the QA activities associated with the design and development of medical devices.y.
• Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
• Excellent interpersonal skills and ability to work with people to achieve results.
• Excellent written and communication skills, fluency in English.
• Experience in preparation for notified body and FDA inspections.
• Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both company and their customers.
• Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
• Proficiency in MS office products.
• Good business acumen.

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