Senior Specialist, Quality Systems

Quality Management System

The Senior Quality Systems Specialist is responsible for enhancing the Quality Management System (QMS) to ensure compliance with all domestic and international laws and standards. This includes reviewing and recommending improvements to the Quality Manual, Standard Operating Procedures, and Work Instructions, collaborating with cross-functional teams to implement and enhance electronic QMS tools, facilitating cross-functional process improvement teams, gathering and compiling quality data, and ensuring all written standards are regularly reviewed and up to date.

• 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

Training and Compliance

The Specialist is responsible for developing and delivering training programs, ensuring compliance with cGMP and ISO requirements, scheduling and executing internal audits, conducting monthly internal walkthroughs, preparing and investigating verification activities, and supporting project teams in implementing quality requirements and procedures.

• 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
• 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
• Affords assistance to 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

The Specialist assists the Document Control department with processing DEV, ECO, ECOT, and MCOs as needed, ensuring all necessary written standards, both systemic and product-specific as defined by Engineering, are up to date and available for use.

• 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

The Specialist assists the Post-Market Surveillance department with initiating Device Investigations, coordinating with Product Development and Marketing Teams to close Device Investigations, and ensuring parts match complaint descriptions.

• Assists the Post-Market Surveillance department with initiating Device Investigations
• Coincides with Product Development and Marketing Teams to close Device Investigations
• Ensures parts match complaint descriptions

General Responsibilities

The Specialist 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, and ensures device labelers meet their UDI obligations.

• 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

Qualifications

The requirements listed below are representative of the education, knowledge, skill, and/or ability required for this position. The education, knowledge, skills, and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

• 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
• Physical Requirements / Adverse Working Conditions: The 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. N/A