You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a Systems Engineer to oversee key quality functions including CAPA, Nonconforming Material, Document Control, and Training programs. This role will serve as a Subject Matter Expert, drive system improvements, and support internal audits. The specialist will collaborate with cross-functional teams to ensure compliance with product and quality requirements, support new product introduction, and assist in process and inspection development.

Key Responsibilities

• Direct oversight of the Nonconforming Material and Corrective and Preventive Action system.
• Direct oversight of the Direct and Indirect Labor Training program.
• Ownership of the document control quality management system.
• Initiate and drive improvements to systems supported by this role.
• Act as primary Subject Matter Expert on systems supported by this role.
• Participate as backup Internal Auditor as time permits.
• Work with cross-functional teams to develop or improve quality systems related to standards and current business needs.
• Participate in Manufacturing Engineering/Operations teams to assure customer product requirements as well as quality requirements are documented and addressed.
• Interface with customer on labeling design, development, and packaging considerations.
• Collaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified.
• Work with Manufacturing Engineering, Operations, and QC Inspection in the development and qualification of processes.
• Assist with the development of inspection processes and equipment if and when required.
• Work with R&D, Manufacturing Engineering, Operations, and Quality, during concept, prototyping, and transfer of new products into production.
• Other assignments as requested.

Qualifications

• Bachelor’s Degree/Technical Degree in applicable field or equivalent industry experience.
• Minimum 5 years’ experience in a Medical Device manufacturing/product development environment.
• Working knowledge of FDA QSR’s, ISO 13485, and ISO 14971 requirements.
• Experience with Nonconforming Material, Corrective and Preventive Actions, Training for both Direct and Indirect Labor, and working knowledge of Quality Management System software.

Experience

• Minimum 5 years’ experience in a Medical Device manufacturing/product development environment.
• Experience/knowledge with product/process verifications/validations.
• Experience with development and support of Quality Systems as they relate to standards.

Skills

• Project management skills and initiative in taking on and completing projects.
• Advanced verbal and written communication skills.
• Ability to manage and prioritize multiple projects/objectives.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.