Job Description
Job Description
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 ResponsibilitiesOperations Leadership
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Direct daily manufacturing functions to achieve and surpass key performance indicators (KPIs) in areas such as output, quality, cost efficiency, safety, and customer satisfaction.
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Establish and sustain a robust operations management framework rooted in Lean and Growth methodologies.
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Collaborate with site leadership to execute the Annual Operating Plan in alignment with broader organizational objectives.
Regulatory and Quality Compliance
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Maintain strict compliance with FDA guidelines, ISO 13485, and GMP standards.
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Partner with Quality Assurance and Regulatory Affairs to support audits, validations, and documentation processes.
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Ensure all manufacturing practices meet health, safety, environmental, and quality management system (QMS) requirements.
Team Development and Engagement
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Cultivate a high-performance team culture through proactive issue resolution and employee engagement.
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Lead and mentor a team of supervisors, technicians, and operators, fostering skill development and accountability.
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Promote a collaborative and improvement-focused work environment.
Process Optimization
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Drive continuous improvement initiatives using Lean and Six Sigma tools in collaboration with cross-functional teams including Operational Excellence, Quality, Automation, and Engineering.
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Implement process enhancements to boost efficiency and reduce waste.
New Product Integration
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Lead the seamless introduction of new products, processes, and technologies into the manufacturing environment in partnership with Engineering and Quality teams.
Qualifications
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Bachelor’s degree in Engineering, Manufacturing, Life Sciences, or a related discipline.
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Minimum of 5 years’ experience in a regulated manufacturing setting, preferably medical devices, with at least 2 years in a leadership capacity.
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Demonstrated ability to build and lead cross-functional teams.
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In-depth understanding of FDA 21 CFR Part 820, ISO 13485, and GMP.
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Practical experience with Lean manufacturing; hands-on application is a plus.
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Proven track record of achieving manufacturing goals in a regulated industry.
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Proficiency in SAP ERP and Microsoft Office; comfortable working in a KPI-driven environment.
Preferred Qualifications
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Lean/Six Sigma certification (Green Belt or higher).
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Excellent analytical, communication, and interpersonal skills.
Pay Details: $110,000.00 to $150,000.00 per year
Search managed by: Cara Kelly
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
Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.