Why Orthofix?

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!

How you'll make a difference?

The 3rd Shift Lead, Manufacturing is responsible for leading the 3rd Shift Manufacturing team in processing and packaging of products as assigned in accordance with the build plan and forecast demands. Assists Manufacturing Supervisor / Manager in overseeing production team to ensure all production operations comply with SOP's, cGMPs, QSR, GTP, and ISO standards as well as company procedures.

3rd Shift Hours: 9:00pm - 5:30am.

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• Communicates and assigns daily work assignments and production output goals to team members on a regular basis.

• Assists team members throughout the shift to ensure completion of daily tasks.

• Sets team expectations and holds team members accountable for results.

• Assigns team members as necessary to support various projects for both clean rooms, and supporting areas (Final Pack, Autoclave, and Wash Area).

• Actively participates in Lean Initiatives by supporting activities dictated by program/process and function as the SME of the areas.

• Conducts review of production Work Instructions, Forms, Logbooks, and other associated documentation daily.

• Assists and ensures ERP material transactions are completed in a timely manner.

• Works with Material Coordinators on Build Plan changes and communicates updates as needed.

• Understands the Build Plan effectively and schedules resources accordingly.

• Ensures product is sent to sterilization in a timely manner to meet build plan goals and forecast demands.

• Assists in keeping the Clean Rooms organized and in proper order per the 5S Metric standards.

• Assists Manufacturing Supervisor/Manager in overseeing the production team and process and provide updates regularly on team's progress or issues if arises.

• Provides support and participates in PD/Engineering/Validation runs and protocol execution.

• Promotes efficiency, safety, creativity, cooperation, a positive work environment, and teamwork among team members.

• Initiates Non-Conformance Records (NCRs) and assists in the investigation process when required.

• Initiates Work Orders requests to escalate equipment/tooling issues and assists with troubleshooting technique when required.

• Provides conflict resolution to team members by assisting with minor conflict and bring into fruition. In addition, escalating major employee conflict events to supervision.

• Assists and updates the Training Program Metrics to ensure team members are up to date with training curricula.

• Balances line by allocating resources to bottleneck areas to meet the build plan when needed.

• Contributes to employee performance evaluations by providing feedback on team members' performance.

• Attends workshops/seminars/meetings as required to enhance employee development skillset.

• Acts as the point of contact for the production areas in the absence of leadership.

What skills and experience will you need?

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• High School Diploma or equivalent required

Experience, Skills, Knowledge and/or Abilities:

• 2-4 years' experience as a lead or trainer

• 3-4 years of experience in an FDA regulated manufacturing environment, preferably in a Medical Device manufacturing environment

• Strong Mathematical skills

• Knowledge of Good Manufacturing Practices (GMP), Quality System Regulation (QSR) and International Organization for Standardization (ISO)

• Knowledge of ERP/MRP systems

• Excellent computer skills and knowledge of Microsoft software systems

• Experience with Excel; comfortable inputting data, navigating the program and fixing simple equations such as adding and division.

• Excellent communication skills, both verbal and written

• Strong leadership skills with the ability to positively influence others

• Detailed oriented, with strong organizational skills

• Ability to multi-task and prioritize projects to achieve established goals and objectives

• Ability to work with, coach, and mentor team members

• Ability to balance and prioritize multiple projects, duties, and assignments

• Demonstrates ability to adapt to fast-paced, team-oriented work environment

• Demonstrates ability to promote cooperation and teamwork among team members

• Must be proficient in tasks performed (after suitable training period) and have attention to detail

• Ability to analyze, troubleshoots, and resolves problems/issues as they arise

• Ability to work overtime, including evenings, weekends, and holidays

What qualifications are preferred?

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• Associate degree in a technical or science discipline

• Lean Manufacturing and Six Sigma Green Belt

• Certifications Continuous Improvement

Additional Experience, Skills, Knowledge and/or Abilities:

• Uphold teamwork and excellent communication and interpersonal skills

• Experience working in a controlled environment (preferably ISO class 5, 7 & 8)

• Oracle ERP experience

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

The anticipated base hourly rate foran employee who is located in Californiafor this position is$28.00 to$30.00 per hour, plus bonus, and benefits. The finalpayoffered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc.The Company is a multi-state employer and thispay scale may not reflect thepayscale for an employee who works in other states or locations.

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.