San Diego, California, United States · On-site
$125k–$140k/yr
QUALITY MANAGER At Lighteum, we pride ourselves on being more than just a place of work. We are a vibrant, innovative team committed to making a difference in the world of medical device components by enhancing the lives…
Skills: Quality Management System, Quality Assurance, Quality Control, Regulatory compliance, Risk management
San Diego, California, United States · On-site
$115k–$125k/yr
Sr. Manufacturing Engineer At Lighteum, we pride ourselves on being more than just a place of work. We are a vibrant, innovative team committed to making a difference in the world of medical device components by enhancin…
Skills: Lean Manufacturing, Six Sigma, Equipment Validation, CAD/CAM, Statistical Analysis
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The Quality Manager leads Quality Operations and the Quality Management System (QMS) to ensure compliance with regulatory and business requirements. This role provides strategic leadership for Quality Assurance and Quality Control while driving continuous improvement and risk management initiatives.
Candidates must have a bachelor's degree in engineering, manufacturing, or a related field with 5-7 years of experience in the medical device industry. Expertise in quality systems, CAPA processes, and risk management within a regulated manufacturing environment is essential.
QUALITY MANAGER
At Lighteum, we pride ourselves on being more than just a place of work. We are a vibrant, innovative team committed to making a difference in the world of medical device components by enhancing the lives of patients worldwide by delivering innovative, high-quality medical components to the MedTech industry.
Be a part of a team dedicated to playing a role in creating solutions that make a real impact. Your work will contribute to improving lives.
We offer a comprehensive benefits package designed to support our associates' well-being. Our health and wellness benefits feature comprehensive medical, dental, and vision insurance. To promote financial security, we also provide a 401(k) plan with generous company contribution and match, flexible spending accounts, and life and disability insurance. Our paid time off policy is generous, including PTO, sick leave, and paid holidays.
Be a part of our team today!
The Quality Manager leads Quality Operations and the Quality Management System (QMS) for the San Diego site, ensuring compliance with regulatory, customer, and business requirements. This role provides strategic and operational leadership for Quality Assurance and Quality Control, drives continuous improvement and risk management initiatives, and partners with site leadership to enhance product quality, operational performance, and customer satisfaction
The incumbent reports to the Quality Director and is responsible for the overall leadership and effectiveness of Quality Operations and the Quality Management System (QMS) for the San Diego site. The role works cross-functionally with Operations, Production, Engineering, Customer Service, Sales, and other business functions to ensure quality requirements are integrated into manufacturing processes and business operations. The incumbent serves as a key business partner, driving quality performance, regulatory compliance, continuous improvement, and customer satisfaction initiatives.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. The physical requirements and work environment described are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE | |
Bachelor’s degree in engineering, Manufacturing, Quality, or a related field. | Essential |
5-7 years of experience in Engineering and/or Quality, preferably in a medical device industry. | Desirable |
Minimum of 3 years of experience in a supervisory or management role. | Essential |
Experience with quality risk management principles and methodologies within a regulated manufacturing environment. | Essential |
Demonstrated success leading teams, driving change, and improving quality, compliance, and business performance through continuous improvement initiatives. | Desirable |
Demonstrated expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes within a regulated manufacturing environment. | Essential |
Proficient in MS 365 applications | Essential |
Experience utilizing ERP/MRP systems, electronic Quality Management Systems (eQMS), and data analytics and reporting tools to monitor quality performance, compliance, and continuous improvement initiatives. | Essential |
Ability to work effectively in both office and manufacturing environments, including prolonged periods of sitting, standing, walking, computer use, visual inspection activities, occasional lifting of up to 25 pounds. | Essential |
PERSONAL SKILLS AND KEY COMPETENCIES |
Aligning Performance for Success: Focusing and guiding others in accomplishing work objectives. |
Coaching and Developing Self and Others: Providing and welcoming feedback, instruction, and development guidance to help self and others excel in current or future job responsibilities; planning and supporting the development of individual skills and abilities. |
Building Collaborative Relationships: Identifying opportunities and taking action to build strategic relationships between one's areas, teams, departments, units, or organizations including customers, to help achieve business goals. |
Driving Execution: Translating strategic priorities into operations reality; aligning communication, accountabilities, resource capabilities, internal processes, and ongoing measurement systems to ensure that strategic priorities yield measurable and sustainable results. |
Leading Teams: Using appropriate methods and interpersonal styles to develop, motivate, and guide the team to attain successful outcomes and business objective |
Safety: Identifying and correcting conditions that affect employee safety; upholding safety standards. |
Values | |
Innovation | We continuously push the boundaries of possibility through genuine collaboration and continuous improvement, striving for excellence |
Integrity | We operate with honesty and transparency, staying true to our word. |
Accountability | We hold ourselves responsible to superior standards in our work, delivering products that meet the highest levels of quality and precision in the industry. |
Resiliency | We embrace challenges and adapt with agility, ensuring continuous improvement in every aspect of our work. |
Empowerment | We fearlessly challenge the status quo, encouraging initiative from every team member to drive transformative ideas and solutions. |
Community Impact | We take pride in knowing that our work improves lives |
Medical Device Components LLC (MDC) is a global leader in the development and manufacture of precision medical components, purchased by Montagu Private Equity from Johnson Matthey Ltd, to specialize in platinum group metals and high-complexity nitinol-based solutions. With decades of expertise in metallurgy, micromachining, femtosecond laser processing, shape-setting, and electropolishing technologies, MDC serves the world’s leading medical device companies, transforming customer experiences through transparency, speed, and cutting-edge manufacturing technologies. Visit www.lighteum.com for more information. Lighteum Medical is the DBA trade name of Medical Device Components LLC.
Offices: 12205 World Trade Dr, San Diego, CA 92128, US · 64 Lillee Cres, Tullamarine, Victoria 3043, AU · Ave. El Piñón 2000, Módulo A. Col. Dos Divisón Dos. C.P., Mexicali, Baja California 21383, MX · 3810 Oceanic Dr, Suite 201, Oceanside, California 92056, US
Medical Device Components LLC (MDC) is a global leader in the development and manufacture of precision medical components, purchased by Montagu Private Equity from Johnson Matthey Ltd, to specialize in platinum group metals and high-complexity nitinol-based solutions. With decades of expertise in metallurgy, micromachining, femtosecond laser processing, shape-setting, and electropolishing technologies, MDC serves the world’s leading medical device companies, transforming customer experiences through transparency, speed, and cutting-edge manufacturing technologies. Visit www.lighteum.com for more information. Lighteum Medical is the DBA trade name of Medical Device Components LLC.
Offices: 12205 World Trade Dr, San Diego, CA 92128, US · 64 Lillee Cres, Tullamarine, Victoria 3043, AU · Ave. El Piñón 2000, Módulo A. Col. Dos Divisón Dos. C.P., Mexicali, Baja California 21383, MX · 3810 Oceanic Dr, Suite 201, Oceanside, California 92056, US
