Quality Systems Manager

MiniMed•Los Angeles, CA

2d•Onsite

About The Position

In this exciting role as a Quality Systems Manager, you will have responsibility for Returned Goods and Failure Analysis personnel and all related departmental tasks. You will be monitoring all incoming products for proper receipt and escalation as necessary. You will ensure operational monitoring of all processes are measured and tracked accordingly. You will be responsible for minimizing backlogs and ensuring maximum throughput of the team. You will ensure all Corporate and departmental procedures/guidelines are followed. You will coordinate all daily activities and make adjustments as needed to ensure coverage to support all returned products. This position has an important role in the Quality Assurance function. The person in it is responsible for the execution and administration of returned product analysis processes, procedures, and controls in compliance with the evolving and complex US and global requirements of the medical device industry. He/she will need to provide expertise and guidance to the business in interpreting and executing against the quality system elements to ensure compliance. He/she will support customer-focused quality, and quality systems improvements.

Requirements

Requires a Baccalaureate degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience

Nice To Haves

Prior experience managing a returned product analysis department
Understanding of quality system regulations including 21 CFR, 820 as it relates to complaints and returned product analysis
Influence management skills; demonstrated ability to work constructively across all functions of the organization
Experience presenting, interacting, and building effective relationships with regulatory agencies
Excellent communication and presentations skills (articulate and persuasive)
Proven experience in achieving results through influence management

Responsibilities

Oversee the execution of the returned product analysis process, which includes the receipt, analysis and disposition of product returned in relation to complaints
Participate in the generation, revision, and review of quality system documents, including product specific analysis work instructions, consistent with the evolving interpretations of current Good Manufacturing Practices
Ensure compliance with quality system documents applicable to Failure Analysis
Work in close collaboration and partner with other departments and functions, including Research & Development, Manufacturing, Quality, Complaint Trending and Legal to maintain and continuously improve returned product analysis
Supports internal and external audits as it relates to returned product analysis
Provide key performance indicators data for monthly quality reviews and quality management reviews for monitoring the health of the returned product analysis process
Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organization
Support and oversee departmental engineers and technical personnel
Perform other related duties as assigned