Quality Systems Lead
Company: Johnson & Johnson
Posted on: November 22, 2022
Job Description - Quality Systems Lead (2206071357W) Quality
Systems Lead - 2206071357W Description MENTOR, a member of Johnson
& Johnson's Family of Companies, is recruiting for a Quality
Systems Lead Manager -to be located in Irving, Texas in the Dallas
metropolitan area. Mentor was founded in 1969 and has a long, proud
history as a global leader in breast aesthetics. For over 50 years,
our company has rooted itself in a commitment to high-quality
breast implants, science-based innovations and the best results for
patients. We've maintained high standards of design, testing and
safety, and we've earned the respect of the breast aesthetics
community worldwide for our leadership. Being a part of the Johnson
& Johnson Family of Companies, we aspire to be the trusted partner
in breast aesthetics among both consumers and professionals. By
providing a broad range of innovation and clinical-based solutions
we aim to help women maintain, enhance, and restore self-esteem and
quality of life. The Quality Systems Lead Manager will guide -the
day-to-day operations of the Quality Systems staff. Oversees the
development and implementation of processes, procedures, and
corrective actions. Ensures effective communication for Quality
Systems requirements throughout the business. The Quality Systems
Lead Manager is responsible for the overall management and
effectiveness of the site Document Control, Records Management,
Nonconformance (NC) and Corrective and Preventive Action (CAPA)
programs including: Administration of the Document Control, Records
Management, NC, and CAPA systems, facilitation of the local Data
Review Board and Management Reviews, coordination and support of NC
and CAPA project teams, data trending and Change Management/NC/CAPA
reporting and communication with management, team leaders, and
auditing bodies. 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:
- Manage the NC and CAPA processes and systems for the site.
- Manage the Document Control and Records Management processes
for the site.
- Manages the implementation and administration of quality
management systems in accordance with applicable standards.
- Requests data and metrics reports obtained from quality
databases and files for inclusion in management reports.
- Examines results from management reviews, third party
inspections and internal audits and approves proposed corrective
- Represent the site on the world-wide Document Control, Records
Management, NC and CAPA teams.
- Work effectively with other Document Control, Records
Management, NC, and CAPA site leaders to ensure consistent systems
- Provide education and mentoring as needed regarding Document
Control, Records Management, NC, and CAPA.
- Develop and implement measures to monitor the effectiveness of
the Document Control, Records Management, NC, and CAPA
- Lead quality systems and compliance improvement, which result
from Internal / External Audits, Management Review and / or any
other CAPA / NC system indicator.
- Participates as a key member in both external and internal
audits and is responsible for the local Document Control, Records
Management, NC, and CAPA processes and directed inspections.
- Represents the site and collaborates with business partners as
the CAPA Site Leader.
- Facilitates (or delegates Facilitation) and leads the site CAPA
Review Board / Data Review Board / Quality Metrics Review /
- Partner with management to develop and implement meaningful
trending of Change Management, NC and CAPA performance.
- Leverage Process Excellence tools to effectively implement CAPA
using a DMAIC approach. -
- Responsible to mentor both technical and non-technical
resources in investigation, troubleshooting, escalation, and
resolution of product and process quality issues, NC and CAPA.
- Supports the continuous improvement of the Document Control,
Records Management, CAPA and NC processes and electronic system for
managing CAPA and NCs. -
- Responsible for ensuring personnel and Company compliance with
all Federal, State, local and Company regulations, policies, and
- Demonstrate independent understanding and application of core
GMP fundamentals, including but not limited to: Data Integrity
(DI), Good Manufacturing Practices (GMP), and Good Documentation
- 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
- Performs other duties assigned as needed Qualifications
- University/Bachelors Degree or Equivalent
- 8 - 10 years of work experience
- Experience leading NCs and CAPAs.
- Experience in Change Management and Document Control.
- Experience in Records Management.
- Knowledge of regulatory requirements (ISO, QSR, etc.).
- Experience with external auditing bodies.
- Demonstrated project management skills with strong results
- Strong communication, influencing and presentation skills
- Process Excellence Green Belt Certification with demonstrated
problem-solving and statistics skills At Johnson & Johnson, we're
on a mission to change the trajectory of health for humanity. That
starts by creating the world's healthiest workforce. Through
cutting-edge programs and policies, we empower the physical,
mental, emotional, and financial health of our employees and the
ones they love. As such, candidates offered employment must show
proof of COVID-19 vaccination or secure an approved accommodation
prior to the commencement of employment to support the well-being
of our employees, their families, and the communities in which we
live and work. Johnson & Johnson is an Affirmative Action and Equal
Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, age, national
origin, or protected veteran status and will not be discriminated
against on the basis of disability. For more information on how we
support the whole health of our employees throughout their
wellness, career, and life journey, please visit
www.careers.jnj.com . Johnson & Johnson is an Affirmative Action
and Equal Opportunity Employer. All qualified applicants will
receive considerationfor employment without regard to race, color,
religion, sex, sexual orientation, gender identity, age, national
origin,or protected veteran status and will not be discriminated
against on the basis of disability.andEqual Employment Opportunity
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