Description
Director of Operations and Manufacturing
Location: Petaluma, CA (Onsite)
Employment Type: Direct Hire
Compensation: Up to $200,000 annually, based on relevant experience
Overview
Kelly Engineering is seeking a Director of Operations and Manufacturing on behalf of our client in the medical device and pharmaceutical industry. This is a key leadership role reporting directly to the CEO. The Director will oversee all aspects of operations, including manufacturing, supply chain, inventory, procurement, logistics, and facilities. The ideal candidate brings extensive experience within FDA-regulated environments and has a proven ability to drive operational excellence, manage audits, and build high-performing teams.
Responsibilities
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Lead and manage all aspects of manufacturing, production planning, supply chain, inventory, procurement, logistics, and facilities operations.
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Develop and implement strategies to optimize operational performance, including cost reduction, lead time improvement, and capacity planning.
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Ensure compliance with FDA regulations (21 CFR Part 820) and other applicable quality and regulatory standards.
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Oversee execution of production schedules, resource allocation, and adherence to quality standards to meet business and customer needs.
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Collaborate with Quality, Engineering, Regulatory Affairs, and R&D to support new product introductions, design transfer, and continuous improvement.
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Manage budgets, capital investments, and track operational Key Performance Indicators (KPIs).
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Implement lean manufacturing principles, process improvement initiatives, and operational excellence programs.
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Build, mentor, and lead a high-performing operations team that fosters accountability, collaboration, and innovation.
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Ensure facility readiness for audits, inspections, and compliance with health, safety, and environmental regulations.
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Manage supplier relationships and external contract manufacturing operations to ensure continuity and quality of supply.
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Provide regular updates to executive leadership on operational metrics, performance, risks, and improvement initiatives.
Qualifications
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Bachelor's degree in Engineering or related field preferred.
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Minimum 10 years of operations/manufacturing management experience, including at least 5 years in a leadership role within the medical device or pharmaceutical industry.
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Strong knowledge of FDA regulations, including 21 CFR Part 820.
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Proven success in preparing for and leading FDA audits.
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Track record of achieving KPIs and driving operational improvements.
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Excellent leadership, organizational, and strategic planning skills.
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Strong written and verbal communication abilities.
How to Apply
If you meet the qualifications and are interested in this opportunity, please submit your resume for immediate consideration.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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