Job Title: Manufacturing/Operations Manager
Department: Operations
Employment Type: Full-Time
Salary: 110-150k depending on experience

Position Overview

The Manufacturing/Operations Manager will oversee production operations ensuring all manufacturing activities align with customer expectations, quality benchmarks, and regulatory standards such as FDA and ISO 13485. This role requires a dynamic leader with a strong grasp of manufacturing systems and a passion for driving continuous improvement in a regulated, fast-paced setting.

Primary Duties and Responsibilities

Operations Leadership

• Direct daily manufacturing functions to achieve and surpass key performance indicators (KPIs) in areas such as output, quality, cost efficiency, safety, and customer satisfaction.

• Establish and sustain a robust operations management framework rooted in Lean and Growth methodologies.

• Collaborate with site leadership to execute the Annual Operating Plan in alignment with broader organizational objectives.

Regulatory and Quality Compliance

• Maintain strict compliance with FDA guidelines, ISO 13485, and GMP standards.

• Partner with Quality Assurance and Regulatory Affairs to support audits, validations, and documentation processes.

• Ensure all manufacturing practices meet health, safety, environmental, and quality management system (QMS) requirements.

Team Development and Engagement

• Cultivate a high-performance team culture through proactive issue resolution and employee engagement.

• Lead and mentor a team of supervisors, technicians, and operators, fostering skill development and accountability.

• Promote a collaborative and improvement-focused work environment.

Process Optimization

• Drive continuous improvement initiatives using Lean and Six Sigma tools in collaboration with cross-functional teams including Operational Excellence, Quality, Automation, and Engineering.

• Implement process enhancements to boost efficiency and reduce waste.

New Product Integration

• Lead the seamless introduction of new products, processes, and technologies into the manufacturing environment in partnership with Engineering and Quality teams.

Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Life Sciences, or a related discipline.

• Minimum of 5 years’ experience in a regulated manufacturing setting, preferably medical devices, with at least 2 years in a leadership capacity.

• Demonstrated ability to build and lead cross-functional teams.

• In-depth understanding of FDA 21 CFR Part 820, ISO 13485, and GMP.

• Practical experience with Lean manufacturing; hands-on application is a plus.

• Proven track record of achieving manufacturing goals in a regulated industry.

• Proficiency in SAP ERP and Microsoft Office; comfortable working in a KPI-driven environment.

Preferred Qualifications

• Lean/Six Sigma certification (Green Belt or higher).

• Excellent analytical, communication, and interpersonal skills.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance