Our Client, A leading medical device company, based in Galway City are hiring for a Senior Quality Engineer.
- Leads and/or facilitates compliance and improvement activities associated with the quality systems (e.g. CAPA, audit programs, personnel training).
- Monitor compliance with 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 production, project and team environments, including contributing towards the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.
- Preparation and reporting of data on production, environmental monitoring, vendor assessment, non-conformances and supplier corrective actions for use in management review.
- Minimum Bachelor's Degree in Engineering, Science or related technical field.
- 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), ISO 13485:2016, the European Medical Device Directive, and the Canadian Medical Device Regulations.
- Experience in preparation for notified body and FDA inspections.
- SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
- Experience in the QA activities associated with a manufacturing environment including project management skills and leadership ability.
- 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.
- Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on the employer 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.
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
For more information please contact Patrick Brady on firstname.lastname@example.org.
Only people who are eligible to work in Ireland need apply.