Quality Engineer

Quality Engineer x2

Location: Galway, Ireland

Work type: on site

ASAP start - 12 month contract 

Hours: 40

Hourly Pay Rates: €27 - €29

The Role:

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 J&J 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

Duties & Responsibilities:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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 Cerenovus/Johnson & Johnson policies, procedures and applicable regulatory requirements, identifying and implementing process and system improvements as applicable.
• Applies thorough, systematic problem-solving methodologies in identifying, prioritising, 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
• Performs other duties assigned as needed

Required Experience & Education:

• Bachelor's Degree in Engineering, Science or related technical field preferred.
• 3 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. Auditor certification from an industry recognized organisation is beneficial.
• Experience in the preparation for notified body and FDA inspections is 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.
• Experience in less invasive medical device technologies and/or implants preferable.
• Ability to work cooperatively with coworkers and the public.
• Ability to perform duties in accordance with policies and procedures and in to comply with civil rights requirements.
• Required Knowledge, Skills, Abilities and Certification
• 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 judgement/decision making and problem-solving ability, capable of understanding the impact of decision making on both Cerenovus and their customers.
• Motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
• Certified QMS Auditor advantageous.
   

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.

Thank you very much and we look forward to receiving your application.