Johnson & Johnson
Senior Quality Engineer
Title: Senior Quality Engineer
Location: Cerenovus, Galway
Work type: Hybrid, 2 /3 days on site
Start date: As soon as possible
Contract duration: 12 months
Hours: 40 hours a week
Hourly pay rate: €37 - €42.30
Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
To provide QA technical and compliance expertise as part of teams tasked with establishing and assuring system and product quality objectives. Assure compliance to applicable regulations. Lead quality activities such as audits, procedure development, product release, 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.
Duties & Responsibilities:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Responsible for compliance with Cerenovus Policies and Procedures and applicable International Regulations
- Leads and/or facilitates compliance and improvement activities associated with the Neuravi quality system (e.g. CAPA, audit programs, personnel training).
- Monitor compliance with Neuravi policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.
- Apply thorough, systematic problem-solving methodologies in identifying, prioritising, 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.
- Represent Neuravi professionally and positively externally to agencies, vendors and regulators.
- 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.
- 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, suppliers, and others as appropriate.
- Assists department and project leaders in developing and reporting appropriate performance and quality metrics.
- Reviews and approves operational, test and validation data to establish conformance to technical specifications and performance standards for existing, new or modified products and processes, including the review and approval of production records and sterilisation records prior to release of product.
- Provides technical quality guidance to team members, technicians and inspection staff.
- This is primarily an office-based role, but assignments may require placement in a production/cleanroom environment. The successful candidate must be able to travel (national and international) – approx. 5-10% of the role.
- Performs other duties assigned as needed.
- 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
Experience & Education:
- 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 organisation 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.
Required knowledge, skills, abilities, certifications/ licences 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 judgement/decision making and problem-solving ability, capable of understanding the impact of decision making on both Neuravi 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.
Things to remember before applying for this role:
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
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.