A growing medical device and life sciences manufacturer is seeking a Quality Engineer to support quality initiatives across manufacturing operations. This role is responsible for ensuring products, processes, and systems meet quality standards while driving continuous improvement, problem-solving efforts, and compliance within a regulated manufacturing environment.
The ideal candidate will have experience in quality engineering, statistical analysis, root cause investigations, and manufacturing quality systems, preferably within medical device, plastics, or other regulated industries.
Key Responsibilities:
Partner with production and operations teams to monitor product quality and address deviations from established standards.
Support quality objectives that align with customer requirements and business goals.
Lead and participate in root cause investigations, corrective actions, and continuous improvement initiatives.
Analyze quality data and process performance metrics to identify trends and opportunities for improvement.
Support quality planning activities for new and existing products.
Collaborate with engineering and manufacturing teams to ensure products are designed and produced for quality, reliability, and manufacturability.
Conduct and support inspections, audits, validations, and quality reviews.
Maintain accurate quality documentation, records, and reporting within ERP and quality management systems.
Ensure compliance with internal procedures, customer requirements, and applicable regulatory standards.
Support customer, supplier, and internal quality initiatives as needed.
Qualifications: Required
Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical discipline, or equivalent combination of education and experience.
Minimum of 1 year of experience in Quality Engineering, Quality Assurance, or a related manufacturing environment.
Strong understanding of quality systems and manufacturing processes.
Proficiency with Microsoft Office applications.
Excellent analytical, organizational, and problem-solving skills.
Strong written and verbal communication abilities.
Preferred
Experience in medical device, life sciences, plastics, injection molding, or other regulated manufacturing environments.
Working knowledge of ISO 9001 and/or ISO 13485 quality systems.
Expertise in GD&T and interpretation of engineering drawings.
Experience with:
Statistical Process Control (SPC)
Design of Experiments (DOE)
Gage R&R
Process Capability Analysis
Minitab
Familiarity with SolidWorks and vision inspection systems.
Experience utilizing ERP systems in a manufacturing environment.
Full-time onsite position in Fiskdale, MA.
Manufacturing and cleanroom environment exposure.
Ability to wear appropriate PPE when required.
Ability to lift up to 25 pounds and stand, bend, or walk throughout the workday.
Occasional travel to customer, supplier, and company locations.
