Quality Assurance Engineer
About The Position
The Site Quality Assurance Engineer I supports manufacturing and operational quality activities, focusing on investigations, quality data analysis, and process improvement. The role partners with Manufacturing, Operations, Engineering, Supplier Quality, and Regulatory teams to support site quality processes and help ensure products meet regulatory requirements, company standards, and customer expectations. This is a hybrid role requiring regular presence at a manufacturing or operational facility in Chelmsford, Massachusetts, with occasional travel for training, audits, investigations, or multi-site support. Relocation is not offered, and applicants should live within a reasonable commuting distance. ZOLL does not provide immigration-related sponsorship for this role.
Requirements
- Bachelor's degree in Engineering or a related technical discipline.
- At least 2 years of relevant experience in quality engineering, manufacturing engineering, or a related quality or operations role.
- Basic understanding of engineering principles, data analysis, and problem-solving techniques.
- Familiarity with root cause investigation tools and structured problem-solving methods.
- Strong organizational skills and attention to detail, including the ability to manage documentation and follow established processes.
- Strong written and verbal communication skills, including the ability to document findings and communicate with technical stakeholders.
- Ability to work effectively in a remote environment while collaborating across teams and time zones.
- Familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements.
- Hybrid or on-site role requiring regular presence at a manufacturing or operational facility and occasional travel as needed.
- English proficiency at an advanced level.
Nice To Haves
- Experience in a regulated industry, preferably in quality engineering, manufacturing engineering, or a related quality or operations role.
- Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry.
- Experience supporting supplier quality investigations or corrective action activities.
- Experience using quality system tools or data analysis tools.
- Exposure to nonconformance management, MRB processes, process validation, or equipment qualification activities.
Responsibilities
- Support investigations of manufacturing and operational quality issues, including data gathering, documentation, and follow-up actions.
- Analyze manufacturing quality data to identify trends, recurring issues, and opportunities to improve process and product quality.
- Assist with nonconforming material investigations and Material Review Board activities, including documentation, disposition support, and cross-functional coordination.
- Support process validation and equipment qualification through documentation review, participation in quality assessments, and related quality processes.
- Participate in manufacturing process improvement initiatives to improve product quality, process consistency, and quality system effectiveness.
- Assist with supplier quality investigations and corrective action activities.
- Support internal audits, inspection readiness, and regulatory compliance activities.
- Partner with Manufacturing, Operations, Engineering, Supplier Quality, and Regulatory teams to resolve site quality issues and implement effective solutions.
- Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.
- Contribute to continuous improvement initiatives involving manufacturing quality, process performance, and compliance.
Benefits
- Annual bonus in accordance with the company's bonus plan.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
