Senior Quality Engineer, Post Market (Hybrid - Acton, MA.)
Location
Acton, MA
Level
Senior-Level
Department
MedTech
Type
Salary
$85,000 - $128,000
Job Description
Posted on:
2025-07-05
Responsibilities
- Review and support Risk Management activities for compliance with quality regulations.
- Provide guidance for country-specific compliance to distribution laws and regulations.
- Apply systematic problem-solving methodologies to identify and resolve quality issues.
- Lead investigations supporting CAPAs and other quality system areas.
- Collaborate effectively with team members across various levels.
- Generate and maintain accurate records related to quality processes.
- Communicate quality initiatives to support departmental and corporate goals.
Job Requirements
- BS degree in engineering or a related technical/scientific discipline.
- 3 years of experience in an engineering/technical quality/compliance role in a regulated environment.
- Knowledge of QSR Part 820, ISO 13485, and ISO 14971.
- Familiarity with design, verification, and validation methods for medical devices.
- Experience with statistical methods for quality control.
- Strong problem-solving and root cause analysis skills.
- Effective verbal and written communication skills, especially in technical report writing.
