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Quality Operations Teamlead

14 days ago: J&J Family of Companies

Job Description

Role: Quality Operations Teamlead.
Location: Cork, Ireland.
Reports to: Snr Quality Operations Manager.
Description
DePuy Synthes, Companies of Johnson & Johnson, is the largest, most comprehensive orthopedic and neurological business in the world, built upon the strong legacies of two great companies.
DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials.
Our broad array of inspired, innovative and high-quality offerings helps advance the health and wellbeing of people around the world.
DePuy Synthes, who employ over 1000 people in Cork established its manufacturing facility in Cork in 1997 where it manufactures orthopedic knees and hips. In 2014, DePuy Synthes in Cork won the Shingo Prize for Operational Excellence.
Job Purpose
Reporting to the Senior Quality Operations Manager, the primary purpose of the quality operations team lead is to lead professionals in the quality operations team. The role is also responsible for the oversight of compliance activities and systems for the site and for identifying opportunities for improvement within quality.
What you’re great at:
• Are you innovative, tenacious and passionate about Quality?
• Performance and results driven.
• Culturally aware and politically sensitive.
• Flexible.
• A team player.
• Good influencing skills.
• Project Management skills.
• Good generalist (experienced quality person).
• Methodical.
• Good communicator.
As a Quality Operations Teamlead, your typical day may include:
• Lead, mentor and develop a team of professionals in the Quality Operations Team to meet business needs and succession plans.
• Continuous Improvement Focus - Lead compliance improvements, which may result from Quality Operations Review trends and other transformational projects.
• Drive robust quality and compliance execution in the business and drive successful Q&C scorecard metrics by working closely with key stakeholders in the business.
• Encourage, support and direct initiatives and programs that head to improved quality and improved regulatory compliance.
• Oversee all Compliance activity within the facility in conjunction with the Regulatory Compliance and Quality Operations groups. Liaise with management at all levels of the business and produce metrics and present data on site performance at meetings such as the weekly and monthly management meetings. Resolve potential compliance issues with functional Managers / Leaders.
• Oversee the Corrective Action and Preventive Action system so this it is maintained in a manner compliant with local and WW procedures, ISO, QSR and Corporate Requirements.
• Oversee the Non-conformance (NC) system so that it is maintained in a manner compliant with local and WW procedures and ISO and QSR and Corporate Requirements.
• Continue to develop strong working relationships at all levels of the business both internally and externally and ensure that the training needs of the site end users for the ADAPTIV PLM are met.
• Ensure that there are sufficient resources available to support activities such as CAPA, non-conformances, complaints, operations certifications of associates.
• Manage Close Call and Stop Shipment activities for the site.
• Support the internal audit system to both local procedures and expectations of ISO 13485:2003, EN ISO 13485:2012, ISO 14971:2007, EN ISO 14971:2012, CFR Title 21 Part 820 Quality System Regulation 1996 and other regulatory standards outlined in SEP-180.
• Partner with other DePuy Synthes sites/ operating companies to ensure harmonization and alignment with J&J Quality Policies, Guidelines, Programs and Systems.
• Support the DePuy Synthes Quality Systems integration process.
• Ensure compliance with all regulated requirements as outlined in SEP-180.
• Maintain a high level of housekeeping in designated areas and observe all HS&E requirements.
• Operate within the company’s standard operating procedures where applicable, review, maintain and create appropriate procedures for sphere of activity.
• Maintain a good level of housekeeping in designated areas, and observe all HS&E requirements.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each:
• Committed to caring.
• Responsible to our communities.
• Ready to apply our knowledge and know-how.
• Rare in our background and experiences.
• The drivers of our own success.
• Passionate about doing what’s right.
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your real passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com.
Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We are an equal opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Qualifications
Be vital:
To be part of this high performing team you will have great attention to detail and have
• A degree level or similar qualification in a science, mechanical or industrial engineering discipline.
• Minimum 5 years’ experience in a senior quality role within a regulated industry with a minimum of 2 years’ experience in a leadership position.
• Proven ability to successfully manage projects and key site Quality initiatives.

• Proven knowledge of FDA, ISO and MDD GMP requirements regarding medical devices.

Primary Location
Ireland-Cork-Cork-
Organization
Depuy (Ireland) Limited (7386)
Job Function
Quality Control
Requisition ID
1905719399W
Role: Quality Operations Teamlead.Location: Cork, Ireland.Reports to: Snr Quality Operations Manager.DescriptionDePuy Synthes, Companies of Johnson & Johnson, is the largest, most comprehensive orthopedic and neurological business in the world, built upon the strong legacies of two great companies. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings helps advance the health and wellbeing of people around the world. DePuy Synthes, who employ over 1000 people in Cork established its manufacturing facility...