Senior Specialist, Quality Systems

Orthofix•Carlsbad, CA

10d

About The Position

The Senior Quality Systems Specialist is responsible for ensuring the Orthofix Quality System complies with all domestic and international laws and standards. This includes performing internal audits, assisting with external audits, and ensuring all written standards are regularly reviewed and up to date. The role involves continuous quality improvements, maintaining and supporting the Corrective/Preventive Action System, and managing controlled documentation and supporting LMS and PLM Systems. Additionally, the specialist ensures compliance with the FDA's Global Unique Device Identification Database (GUDID) requirements and supports labeling activities in the medical device industry.

Requirements

High School Diploma or equivalent required
3-5 years’ experience in a QA or QC environment
Prior experience successfully implementing Quality Management Systems and electronic Quality System tools in regulated medical device and/or diagnostic companies
Expert knowledge of U.S. FDA Quality System Regulations (21 CFR 801, 803, 806, 807 and 820), ISO 13485, ISO 14971, European Union Medical Device Directive (MDD) and the Canadian Medical Device (CMDR) regulatory and standard requirements
Prior experience successfully implementing electronic Quality System tools such as Agile, Reliance EtQ, Master Control, Oracle, Pilgrim, etc.
Expert in LMS systems for company’s Quality Management System training requirements
Ability to operate effectively in a cross-functional team environment
Excellent written and oral communication skills
Ability to organize time and tasks efficiently
Ability to work with both LMS and PLM systems
Excellent analytical skills
Knowledge of domestic and international laws and standards required
Must be able to interpret device law into workable, efficient and effective practices and procedures
Must be able to maintain documents accurately and completely
Must be able to generate and implement an internal audit schedule
Must have good written and verbal communication skills

Nice To Haves

Bachelor’s Degree
Degree in engineering or scientific discipline
5+ years’ experience in a QA or QC environment
Knowledge of Microsoft Office products
Knowledge of internet investigation for new and updated standards
Knowledge of QMS Learning Management Systems

Responsibilities

Reviews and recommends improvements to the Quality Management System (Quality Manual, Standard Operating Procedures, and Work Instructions)
Collaborates with cross-functional teams to implement and enhance electronic Quality System tools
Facilitates cross-functional process improvement teams to drive operational excellence
Gathers, compiles, and reports on Quality data
Reviews documents to ensure the Quality System complies with all applicable laws and standards and is as efficient and effective as possible
Administers the online training program for the Quality Management System
Designs, delivers, and evaluates the QMS training program
Generates monthly training reports to ensure training effectiveness and compliance
Continuously updates training matrices for efficiency
Supports project teams in implementing quality requirements and procedures
Provides cGMP and ISO training to employees
Schedules and executes internal audits to ensure all quality system elements are audited at least annually
Conducts monthly internal walkthroughs to support audit readiness
Prepares, investigates, and follows up on verification activities associated with the Corrective/Preventive Action system
Assists the Head of QA department with preparation for and activities associated with external audits by FDA, Notified Body, and others
Assists the Document Control department with processing DEV, ECO, ECOT, and MCOs as needed
Ensures all necessary written standards, both systemic and product-specific as defined by Engineering, are up to date and available for use
Assists the Post-Market Surveillance department with initiating DIFs
Coordinates with Product Development and Marketing Team to close the Device Investigation.
Ensures parts match complaint descriptions
Supports company and department goals and objectives
Prepares, submits, and manages GUDID data to the FDA
Maintains the accuracy and completeness of device information within the GUDID, ensuring device labelers meet their UDI obligations