Manufacturing, Lead

4 weeks ago

Irvine, United Kingdom Orthofix Full time

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?

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?

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?

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 anticipated base hourly rate for an employee who is located in California for this position is $ to $ per hour, plus bonus, and benefits. The final pay offered 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 this pay scale may not reflect the pay scale for an employee who works in other states or locations.

DISCLAIMER

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