Engineer, Quality Engineering

We are seeking a motivated Quality Systems Engineer to join our team. This role supports the development, implementation, and maintenance of quality management systems for medical devices, ensuring compliance with ISO 13485, FDA regulations, and EU MDR. The position also includes responsibilities as a Training Coordinator for the Quality Engineering group.

Key Responsibilities

• Assist in the development, implementation, and maintenance of the Medical Quality Management System (MQMS) in accordance with ISO 13485, 21 CFR 820, EU MDR, and other applicable standards.

• Support quality system processes including CAPA, Internal Audits, Document Control, Change Management, Training, and Management Review.

• Support the coordination and administration of training activities:

• Organize and schedule training sessions for team members or stakeholders.

• Maintain accurate training records and track completion status.

• Assist in the development of training materials and in evaluating the effectiveness of training programs.

• Coordinate and administer initial, ongoing, and re-training activities for employees, contractors, and temporary personnel.

• Assign and track mandatory quality, regulatory, and job-specific training per approved procedures and curricula.

• Maintain accurate, complete, and inspection-ready training records in compliance with FDA and ISO requirements.

• Identify and coordinate retraining needs resulting from SOP, process, product, or regulatory changes

• Participate in internal and external audits, ensuring compliance with regulatory standards.

• Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address quality issues.

• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure product quality and safety.

• Perform risk assessments and support the development of risk management plans.

• Review and approve quality documentation, including SOPs, work instructions, and validation protocols.

• Support the investigation and resolution of customer complaints and non-conformances.

• Assist in the preparation of quality reports and metrics for management review.

• Support compliance with 21 CFR Part 11 for electronic records and signatures, including validation and oversight of quality system software tools.

• Help maintain history files, risk management documentation, and post-market surveillance processes.

• Participate in root cause investigations and failure analysis efforts using quality tools and methodologies.

• Support validation planning and execution for new product designs and manufacturing processes.

Qualifications

• Bachelor’s or Master’s degree in Biomedical Engineering, Manufacturing Engineering, Electrical Engineering, Mechanical Engineering, or a related field.

• Understanding quality management principles and regulatory requirements in the medical device industry.

• Excellent analytical and problem-solving skills.

• Effective communication and interpersonal skills.

• Ability to work independently and as part of a team.

• Proficiency in Microsoft Office Suite and quality management software.

• Familiarity with regulatory requirements including US CFR (Code of Federal Regulation), ISO (International Organization for Standardization), GMP (Good Manufacturing Practice), and EU MDR (Medical Device Regulation).

• Knowledge of FDA 510(k) clearance, FDA Premarket Approval (PMA), and ongoing submission maintenance requirements.

• Internship or co-op experience in a quality engineering role within the medical device industry (preferred).

• Knowledge of statistical analysis and quality improvement tools (e.g., Six Sigma, Lean) (preferred).