Quality Engineer

Position Summary

The Quality Engineer is responsible for ensuring that products meet all regulatory, customer, and internal quality requirements throughout the product lifecycle. This role supports quality assurance operations, participates in design and process validations, interfaces with regulatory and testing partners, and contributes to regulatory submissions. The position also leads document control and supports cross-functional teams to drive product quality and compliance.

Essential Duties and Responsibilities

Quality Management System (QMS) Compliance

Ensure adherence to FDA 21 CFR 820, ISO 13485, and other applicable standards.

Participate in internal audits, CAPA, non-conformance, and complaint investigations.

Maintain document control and change control systems.

Regulatory Documentation Support

Contribute to regulatory submissions such as FDA 510(k), Design History Files (DHF), and substantial equivalence justifications.

Prepare or review technical documentation including device description, executive summaries, and sterilization equivalency reports.

Biocompatibility and Laboratory Coordination

Coordinate external testing for EO residuals, pyrogenicity, endotoxins, sensitization (e.g., GPMT), and chemical analyses (e.g., NMR, IR).

Review lab protocols and final test reports to ensure compliance with ISO 10993 standards and internal specifications.

Validation & Risk Management

Support sterilization validation, process validations, and EO re-qualifications.

Participate in risk assessments in accordance with ISO 14971 and product safety evaluations.

Design Control Participation

Support design and development teams by contributing to DHF artifacts, including design inputs/outputs, risk analysis, and labeling.

Labeling & Packaging Compliance

Review product labels, IFUs, and artwork for regulatory and quality compliance.

Support implementation of changes to packaging or label content per control procedures.

Cross-functional Quality Support

Actively participate in project meetings with R&D, Regulatory, Operations, and external partners.

Provide input on quality requirements and timelines in product development and improvement projects.

Supplier and Production Quality

Collaborate with production and supply chain teams to review batch records, conduct in-process inspections, and resolve quality issues.

Support supplier evaluations and incoming inspection activities.

Training and Knowledge Sharing

Assist with training staff on QMS procedures and regulatory updates.

Promote a culture of continuous improvement and compliance.

Qualifications

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.

Minimum 2-4 years of experience in Quality Assurance or Regulatory Affairs in the medical device or life sciences industry.

Working knowledge of FDA QSR, ISO 13485, ISO 14971, and ISO 10993 standards.

Experience with document control systems and regulatory submissions (510(k) preferred).

Strong interpersonal, analytical, and organizational skills.

Preferred Skills

Experience coordinating third-party lab testing.

Familiarity with sterilization methods (e.g., EO, gamma).

Knowledge of DHF structure and labeling regulations.

Ability to manage multiple priorities and work in cross-functional teams.