Job summary: We are looking for a highly motivated individual to oversee the overall direction and function of an FDA and ISO 13485-compliant quality management system. The Director of Quality is responsible for planning, developing, and directing quality policies, programs, and initiatives; maintaining compliance with FDA and ISO quality regulations and standards; directing quality control activities related to in-house manufacturing

Functions and responsibilities

Manage the entire company's Quality Management System.

Identify and implement QSM improvements to ensure operation efficiency and compliance with FDA and ISO standards.

Oversee and manage NCMR, CAPA, and customer complaint programs; ensure timely and effective investigation, disposition, and closure.

Manage company-wide controlled document procedures used in Good Manufacturing Practices.

Manage in-process product inspection standards, product rework, and dispositions standards by studying manufacturing methods, and devising testing methods and procedures.

Participate in the Design Control Process to develop inspection instructions, and risk management plans, facilitate hazard analysis, administrate and facilitate FMEAs, project technical reviews, and deliver the final risk profile for all assigned projects.

Serve as management representative during governmental, customer, or third-party reviewer audits as well as lead internal audits.

Manage supplier qualifications, approvals, and audits/evaluations.

Maintain company Quality records including device history files, environmental monitoring records, calibration, and preventative maintenance schedules.

Perform other duties as assigned.

Required skills and abilities

Minimum 5 years of experience in a quality management role working with Class II medical devices.

Advanced knowledge of QSR 21CFR820 and ISO 13485.

Strong understanding of statistics and statistical process controls.

Ability to understand and interpret drawings, specifications, schematics, work instructions, quality assurance procedures, test instructions, and quality plans.

Effective, logical reasoning and interpretive skills.

Excellent interpersonal, written, and verbal communication skills.

Preferred skills and experience

Bachelor’s degree

Certified Quality Engineer (CQE), and/or Certified QualityAuditor (CQA) is preferred.

Experience at orthopedic implant and instrument companies.

Experience in VisualVault (Cloud-based Quality System)

To be considered for this position, you must submit a cover letter with a brief explanation of why you're applying for this position and what qualifications you have to fulfill this role.