Overview
Quality Engineer Jobs in Wakefield, Massachusetts, USA at ACE Partners
Quality Engineer – Wakefield, MA – $100k – $120k
US Citizen or GC holders only
No C2C
This role ensures that design changes for new and existing catheter and console products meet regulatory and quality standards throughout the design, development, and manufacturing transfer processes. Achieving this will involve close collaboration with cross-functional teams. The Quality Engineer will be involved in all product development phases, including design, reliability testing, design controls, feasibility assessments, verification and validation, process development, risk management, and delivery.
Responsibilities:
Focus on sterile disposable and electrical hardware product design.
Participate in design control, project planning, and quality reviews.
Review and provide feedback on requirements, specifications, and design documents.
Draft and review design control deliverables for product and design changes.
Contribute to risk analysis (FMEAs, hazard analysis, etc.) and manage risk requirements.
Approve design, verification, and validation protocols and test reports.
Support process validation (IQ/OQ/PQ) and root cause investigations for design and process issues.
Assess changes for impacts on sterility, biocompatibility, and shelf life.
Design inspection and testing methods for production processes and products.
Analyze production data to update quality standards as needed.
Support regulatory audits and responses.
Lead CAPA efforts and apply root cause problem-solving.
Perform statistical quality analysis.
Experience & Qualifications:
3-5 years in sterile disposable and electro-mechanical device engineering.
Bachelor’s degree in science, engineering, or related field (or equivalent experience).
Experience in medical device design assurance and manufacturing transfer.
Knowledge of ISO 13485, FDA 21 CFR 820.30, ISO 14971, and related regulations.
Strong communication skills and ability to thrive in small, cross-functional teams.
Proactive team player with a solution-oriented mindset.
Title: Quality Engineer
Company: ACE Partners
Location: Wakefield, Massachusetts, USA
Category: Engineering, Quality Assurance – QA/QC
