Overview
Quality Engineer Jobs in Boston, MA at Maclivaro Limited
Title: Quality Engineer
Company: Maclivaro Limited
Location: Boston, MA
Quality Engineer
Medical Devices | Orthopaedics | Permanent | Full-Time
Boston, Massachusetts
Salary: Around $80,000 + Benefits
Are you a hands-on Quality Engineer looking to make a real impact within an innovative medical device company?
We're partnering with a growing medical device manufacturer based in the MetroWest Boston area that is developing cutting-edge orthopaedic technologies designed to improve patient outcomes. As the business continues to expand, they're looking to hire a motivated Quality Engineer who enjoys working closely with manufacturing, engineering, and operations to ensure products meet the highest quality and regulatory standards.
This is an excellent opportunity for someone with 3–5 years of quality engineering experience who wants to take ownership, develop their career, and play a key role in bringing life-changing medical devices to market.
What You'll Be Doing
As a Quality Engineer, you'll be a key contributor to the day-to-day quality activities across the product lifecycle, working in a collaborative and fast-paced environment.
Your responsibilities will include:
- Investigating and resolving Non-Conformance Reports (NCRs) and driving effective corrective actions.
- Leading and supporting CAPA investigations, root cause analysis, and implementation of preventive actions.
- Performing product and process inspections while ensuring compliance with quality standards.
- Supporting internal and external audits and helping maintain audit readiness.
- Working cross-functionally with Engineering, Manufacturing, Operations, and Supply Chain to solve quality issues.
- Assisting with continuous improvement initiatives to enhance manufacturing processes and product quality.
- Reviewing manufacturing documentation and supporting quality system activities.
- Participating in risk assessments and process improvements.
- Supporting validation and verification activities where required.
- Ensuring compliance with FDA regulations, ISO 13485, and company quality procedures.
What We're Looking For
- Bachelor's degree in Engineering or a related technical discipline.
- 3–5 years of Quality Engineering experience within the medical device industry.
- Experience working with:
- CAPA
- NCR investigations
- Product or process inspections
- Root Cause Analysis
- Quality Management Systems
- Previous engineering or manufacturing experience would be highly advantageous.
- Knowledge of FDA Quality System Regulations and ISO 13485.
- Experience within Orthopaedics or another regulated medical device environment is highly desirable.
- Excellent communication skills and the ability to work collaboratively across multiple departments.
- A proactive, hands-on mindset with a passion for continuous improvement.
Why Join?
- Join an innovative medical device company making a genuine difference to patients' lives.
- Work on exciting orthopaedic technologies in a collaborative engineering environment.
- Gain exposure across quality, manufacturing, and product development.
- Be part of a company where your ideas are valued and your contributions have real impact.
- Excellent opportunity for career progression and professional development.
- Competitive salary of approximately $80,000, plus comprehensive benefits.
- Full-time, permanent position based in the MetroWest Boston area.
If you're an ambitious Quality Engineer looking for your next challenge in the medical device industry, we'd love to hear from you.
