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:
2025-06-13
Responsibilities
- Reviews and supports Risk Management activities related to quality regulations.
- Provides guidance for compliance with country-specific laws and regulations.
- Applies systematic problem-solving methodologies to resolve quality issues.
- Leads investigations supporting CAPAs and other quality system areas.
- Communicates effectively with all organizational levels regarding quality initiatives.
- Maintains accurate records and follows up on open tasks.
- Collaborates with team members to meet departmental and corporate quality goals.
Job Requirements
- BS degree in engineering or related technical/scientific discipline.
- 3 years of experience in a quality/compliance role within a regulated environment.
- Knowledge of QSR Part 820, ISO 13485, and ISO 14971.
- Experience with medical device design, verification, and validation.
- Proficiency in statistical methods and quality control techniques.
- Strong verbal and written communication skills, including technical report writing.
- Ability to prioritize tasks and lead problem-solving initiatives.
