Calibration Site Lead

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 mínimally 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 mínimally 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.

**Qualifications**:

- BS Engineering with 4 years experience or associate degree with minimum of 8 years
- Metrology experience in a regulated industry

**Other**:
Travel percentage: 1