How you'll make a difference? 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.
What will your duties and responsibilities be? The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.
Quality Management System Enhancement:- 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
Develop and Deliver Training:- 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
Conduct and Ensure Compliance:- 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
Document Control and Data Management:- 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
Post-Market Surveillance and Support:- Assists the Post-Market Surveillance department with initiating DIFs
- Coordinates with Product Development and Marketing Team to close the Device Investigation.
- Ensuring parts match complaint descriptions
General Responsibilities:- 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
What skills and experience will you need? The requirements listed below are representative of the education, knowledge, skill, and/or ability required for this position.
Education/Certifications: - High School Diploma or equivalent required
Experience, Skills, Knowledge, and/or Abilities:- 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
What qualifications are preferred? The education, knowledge, skills, and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.
Education/Certifications: - Bachelor's Degree
- Degree in engineering or scientific discipline
Additional Experience, Skills, Knowledge, and/or Abilities:- 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
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONSThe physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.
The anticipated salary for this position for an employee who is located in California is $101,953 to $131,017 per year, plus bonus, and benefits.
DISCLAIMER The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.
