Quality Manager

Medical Device Components LLC•San Diego, CA

14d•$125,000 - $140,000•Onsite

About The Position

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!

Requirements

Bachelor’s degree in engineering, Manufacturing, Quality, or a related field.
5-7 years of experience in Engineering and/or Quality, preferably in a medical device industry.
Experience with quality risk management principles and methodologies within a regulated manufacturing environment.
Demonstrated success leading teams, driving change, and improving quality, compliance, and business performance through continuous improvement initiatives.
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.
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.

Nice To Haves

Minimum of 3 years of experience in a supervisory or management role.
Demonstrated expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes within a regulated manufacturing environment.
Proficient in MS 365 applications

Responsibilities

Responsible for the Quality Management System (QMS) and Quality Operations, ensuring compliance with applicable regulatory, customer, and business requirements.
Provide leadership, coaching, talent development, and performance management for Quality Assurance and Quality Control teams.
Develop, implement, and maintain quality systems, procedures, controls, and metrics to ensure consistent product and process quality to meet customer expectations and quality standards.
Establish quality objectives and KPIs aligned with business goals to drive compliance, operational excellence, and continuous improvement.
Leads quality risk management for products, processes, suppliers, and quality systems across the product lifecycle.
Ensures effective management of CAPA, nonconformances, deviations, complaints, adverse events, and change controls.
Lead Management Reviews and provide executive leadership with updates on quality performance, compliance, risks, and improvement initiatives.
Direct internal, supplier, customer, certification, and regulatory audit programs and ensure timely closure of findings and corrective actions.
Ensures audit readiness and leads Quality representation during customer, certification, and regulatory inspections.
Partner with cross-functional teams to integrate quality requirements throughout the product lifecycle and business processes.
Establishes and maintains an effective supplier quality management program, including supplier qualification, monitoring, audits, performance reviews, and corrective actions.
Promotes a prevention-based quality culture through employee training, risk management, process controls, data analysis, and continuous improvement initiatives.
Provides leadership and direction to the Quality team through frontline supervision, ensuring effective execution of quality controls, compliance activities, and continuous improvement initiatives.
Other duties as assigned.