Job Details

This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$100,000.00/yr - $115,000.00/yr

Additional compensation types

Annual Bonus

Role

We're seeking a hands‑on and detail‑oriented Quality Engineer to join our growing Quality Assurance and Regulatory Affairs team. The ideal candidate will have a strong engineering background with experience across the full product lifecycle—from design through manufacturing—within the medical device industry.

This individual will play a key role in shaping and strengthening our Quality Management System (QMS), with opportunities to lead validation, process improvement, and regulatory readiness initiatives.

Role & Responsibilities

• Partner with R&D to define product requirements and release criteria; support design reviews and ensure robust technical documentation.
• Lead risk management activities (FMEA/DFMEA/PFMEA) and maintain traceability throughout the design process.
• Author, maintain, and execute design verification and validation (V&V) protocols and reports; lead hands‑on test method validations (TMVs) and formal V&V testing.
• Execute and document intended‑use and computer system validations, ensuring systems meet regulatory and business needs.
• Drive QMS remediation and continuous improvement initiatives—identify procedural or documentation gaps proactively, develop and implement sustainable fixes, and ensure alignment with FDA QMSR and ISO 13485.
• Draft, revise, and maintain SOPs and quality procedures; support internal audits, CAPA, and monitoring of quality metrics.
• Contribute to regulatory submissions (e.g., 510(k), Letters to File, labeling, technical documentation) and ensure compliance with global regulatory standards.
• Oversee supplier qualification, conduct supplier audits, and drive supplier corrective and preventive actions (SCARs).
• Develop inspection plans; support inventory control, equipment/tool calibration, and process validation (IQ/OQ/PQ) activities.
• Collaborate across Operations, Manufacturing, and Supply Chain to communicate risks, mitigations, and timelines effectively.
• Mentor junior team members and help foster a culture of continuous learning and improvement.

Requirements

• Bachelor's degree in Engineering or a related technical field.
• 2–4 years of quality engineering experience in the medical device or diagnostics industry (additional experience considered for Senior title).
• Working knowledge of FDA QMSR, ISO 13485, ISO 14971, and experience with lifecycle documentation in regulated environments.
• Proven experience in QMS remediation or enhancement—demonstrated ability to identify process or documentation gaps and implement proactive, scalable solutions.
• Hands‑on validation experience (e.g., developing and executing TMV, IQ/OQ/PQ, and process validation activities).
• Preferred familiarity with 510(k) submissions and/or EU MDR technical documentation.
• Exposure to early‑stage or startup environments where adaptability and cross‑functional collaboration are key.
• Strong technical writing, attention to detail, and data‑driven problem‑solving skills.
• Excellent communication and stakeholder management skills; able to clearly articulate findings, risk assessments, and recommendations.
• Ambitious, career‑driven, and self‑motivated—someone with a clear vision for their professional growth and the drive to make an impact in a scaling organization.

Seniority level

Associate

Employment type

Full‑time

Job function

Quality Assurance and Engineering

Industry

Medical Equipment Manufacturing