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# Senior Design Quality Assurance Engineer - Medical Device #8944

- **Company:** Enhanced Compliance Inc.
- **Location:** Marlborough, MA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Failure Mode Effects Analysis, Requirements Management, Requirements Traceability
- **Published:** October 12, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=db9d109790f6b027

## About the Role

* Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
 * 3-5 years of experience in the medical device industry or another regulated environment.
 * Working knowledge of Design Controls, Risk Management, and Product Development processes.
 * Familiarity with FDA Quality System Regulation, ISO 13485, ISO 14971, and applicable medical device regulatory requirements.
 * Strong technical writing and documentation skills.
 * Demonstrated ability to independently manage multiple priorities and deliver high-quality results with minimal supervision.
 * Strong analytical, organizational, and problem-solving skills.
 * Effective communication skills and the ability to work across functions and global teams.

Preferred Qualifications

 * Direct experience with DHF remediation, design assurance, quality engineering, or CAPA-related activities.
 * Experience supporting remediation programs, compliance initiatives, or regulatory commitments.
 * Knowledge of traceability methodologies and requirements management.
 * Experience reviewing and creating risk management documentation, including DFMEAs and hazard analyses.
 * Experience within Endoscopy or Class II/III medical device product development environments.
 * Working knowledge of design control requirements under 21 CFR Part 820 and ISO 13485.

## Description

* Participate in Design History File (DHF) remediation activities to ensure compliance with applicable design control requirements, regulatory expectations, and company procedures.
 * Review and assess existing design documentation to identify gaps, inconsistencies, and opportunities for improvement.
 * Develop and execute remediation strategies for design inputs, design outputs, design verification, design validation, design reviews, risk management, and traceability documentation.
 * Partner with cross-functional teams to reconstruct product development history and establish objective evidence supporting design decisions.
 * Author, revise, and review quality records and remediation deliverables to support audit readiness.
 * Support the development and maintenance of requirements traceability matrices and design control documentation packages.
 * Participate in risk management activities, including hazard analyses, design FMEAs, and risk/benefit assessments.
 * Apply structured problem-solving methodologies to resolve complex documentation, compliance, and process challenges.
 * Collaborate with global stakeholders to drive alignment and execution of remediation plans.
 * Interpret and apply FDA, ISO 13485, ISO 14971, and internal quality system requirements within remediation activities.
 * Support internal audits, inspections, and remediation effectiveness reviews as required.
 * Identify opportunities to improve remediation processes, tools, and methodologies, increasing efficiency while maintaining compliance.
 * Serve as a design controls resource and related quality remediation initiatives.