Job Description

Company Overview: Tympanogen is a medical device company based in Richmond, VA with a mission to improve healthcare by simplifying surgical procedures. We develop gel-based medical devices for the ear, nose, and throat industry and transform eardrum repair surgery into an office-based procedure.

Job Summary: We are hiring a Quality Engineer II to ensure the development, production, and delivery of the Company’s medical devices meet customer needs in accordance with the Company’s quality management system (QMS) and regulatory requirements. This hands-on position reports to the Quality Systems Manager and works closely with multifunctional team members, combining quality engineering expertise with document control and continuous improvement initiatives. All activities are performed within an FDA 21 CFR 820 and ISO 13485 compliant quality management system (QMS), alongside additional, relevant standards. An ambitious candidate with a track record of successful medical device compliance who wants to lead onsite quality activities and uphold rigorous standards of compliance and quality culture in a fast-growing startup would thrive in this role.

Key Responsibilities:

Quality Activities:

• Lead all on-site quality activities, including equipment and process validations, supplier quality qualifications, non-conformances, CAPAs and internal audits.
• Conducts nonconformance investigations and carries out product containments (eg, quality assurance holds, quarantines) and dispositions (scrap, returns, sorts, reworks, etc.)
• Reviews and approves work instructions, forms, batch records, protocols, reports, equipment files, specifications, etc.
• Lead root-cause analysis and problem-solving for quality issues identified on-site.

Document Control:

• Authors, reviews, routes for approval and files/stores QMS and technical documents.
• Help maintain the document control system in compliance with regulatory and ISO standards for documentation, including ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
• Facilitate and support internal and external audits by providing controlled documents and records.

Continuous Improvement:

• Identify opportunities for process improvements and support streamline processes streamlining initiatives while ensuring the highest degree of quality.
• Support the implementation of quality system updates and improvements to address regulatory changes and audit findings.
• Participate in cross-functional teams to optimize manufacturing processes, ensure product design and manufacturing meet compliance standards, and reduce quality risks.

Mentorship & Team Development:

• Maintain compliance with all company policies and procedures.
• Foster a collaborative and growth-oriented work environment by encouraging knowledge sharing, continuous learning, and teamwork.
• Provide training and guidance to team members on quality system procedures and best practices.
• Communicate regularly with senior leadership about ongoing operations and project progress.

Preferred Qualifications:

• Bachelor’s degree in a relevant scientific or engineering discipline, Master’s degree preferred;
• Minimum 3 years of quality assurance experience in the medical device industry with a track record of operating within an ISO 13485-compliant system;
• Certified Quality Auditor certification preferred;
• Experience authoring process validation protocols and reports;
• Organized and detail-oriented with an ability to author, review, route, and file technical documentation;
• Working knowledge of medical device-relevant QMS including ISO 13485 and 21 CFR 820.
• Strong oral and written communication skills and interpersonal skills;
• Ability to multi-task and work within a fast-paced dynamic team environment;
• High degree of initiative and self-motivation.

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