Calibration Site Lead
Company: Disability Solutions
Location: Raritan
Posted on: May 8, 2024
Job Description:
At Johnson & Johnson, we believe health is everything. Our
strength in healthcare innovation empowers us to build a world
where complex diseases are prevented, treated, and cured, where
treatments are smarter and less invasive, and solutions are
personal. Through our expertise in Innovative Medicine and MedTech,
we are uniquely positioned to innovate across the full spectrum of
healthcare solutions today to deliver the breakthroughs of
tomorrow, and profoundly impact health for humanity. Learn more at
Ethicon is recruiting for a Site Calibration Instrument Officer,
R&D located in Raritan, NJ. The Ethicon business offers a broad
range of products, platforms and technologies-including sutures,
hemostasis products, surgical staplers, trocars, energy devices and
synthetic mesh devices-that are used in a wide variety of minimally
invasive and open surgical procedures. Specialties include support
for treatment of colorectal and thoracic conditions, women's health
conditions, hernias, oncology, and obesity. The Ethicon business
combines products and services of two market leading legacy
companies, both with long histories of medical innovation. Ethicon,
Inc. based in Raritan, New Jersey, was founded more than 80 years
ago as a pioneer in suture development and manufacturing, helping
to transform the safety and effectiveness of open surgery. Ethicon
Endo-Surgery, Inc. was built more than 20 years ago in Cincinnati,
Ohio, developing creative devices that have driven the
groundbreaking shift from open to minimally invasive surgery that
continues to lead the industry today. A position is available in
R&D and may include some or all of the following
responsibilities: Job summary Manages all aspects of calibration
for the R&D teams at the Raritan, NJ site, including the
instrument calibration program and daily activities of the
calibration support staff. Will exercise control theory knowledge
and metrology basics as required in a strict regulatory
environment. 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 will include:
- Manage and ownership of the site calibration program to the
Ethicon Franchise governing documents for calibration, identifying
and implementation change control opportunities to support the
R&D laboratories.
- Supervision of the contract instrument technicians, providing
daily guidance and support.
- Interface/collaborate with R&D engineers/scientist to
ensure equipment is appropriately calibrated, tolerances are
appropriate, and calibration range is appropriate for use
- Ensure that calibration personnel are qualified to perform
assigned tasks and/or is periodically trained as needed and ensures
calibration policies and procedures are followed
- Creates, maintains, and updates calibration job plans, as
required, ensuring compliance
- Ensure all monthly calibrations are completed on time.
- Maintain the calibration software systems including associated
budgets.
- Assist in defending maintenance/calibration records during
regulatory audits (FDA, ISO, internal regulatory, etc.) and assist
with any subsequent audit finding responses and
investigations.
- Ensure compliance to Safety, Environmental, Energy, ISO, GMP
and Ethicon/J&J directives/objectives .
- Develop solutions to calibration/equipment problems and issues
of moderate scope and complexity to support R&D
operations.
- Ensure that the current validated calibration database program
is setup and maintained.
- Owns and provides oversite of scheduling of calibration
activities, including calibration system records, opening and
investigating non conformances/observations, calibration
equipment/standards inventory, data entry, calibration workload,
and calibration files.
- Ensures that the vendors selected for performing calibrations
is listed within the approved supplier listing (ASL) and
calibrations meet all requirements of internal procedures Other
responsibilities
- Knowledge of standard metrology practices and common technical
requirements/calibration requirements for standard laboratory
equipment, including, but not limited to, rulers, pipettes,
balances, force gauges, chambers, incubators, etc.
- Knowledge of Good Documentation Practices and Good
Manufacturing Practices
- Work in team environment behaving in a CREDO based respectful
manner.
- Comply with all federally regulated programs.
- Adhere to J&J laboratory, environmental and safety policies
and guidelines.
- Comply with all job specific safety procedures and utilize PPE
when necessary.
- Comply with quality system requirements as defined within
procedures and instructions.
- Use test equipment (Starett Gauge, Mitutoyo Gauge, Microscope,
Instron,etc) where applicable.
- Utilize applicable software systems as needed for the job (e.g.
ComplianceWire, ADAPTIV, Maximo, etc.)
- Consistently meet required work performance targets (RE's), if
applicable
- Support LEAN and Six Sigma Initiatives.
- Accurately complete records as defined within the job
procedures (e.g'. manual and/or electronic documentation).
- Perform other work-related duties as assigned by
supervisor.
- Consistently meet required Training due date targets.
Keywords: Disability Solutions, Edison , Calibration Site Lead, Other , Raritan, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...