Division Quality Engineer I

Corning • Tewksbury, MA

4d • $67,237 - $92,451 • Hybrid

About The Position

As a Quality Engineer I, you will support product quality across the full lifecycle—from innovation and design through manufacturing and continuous improvement. You’ll apply quality engineering principles and statistical methods to ensure products meet evolving customer, regulatory, and business requirements. This role partners cross-functionally with Manufacturing, R&D, Quality, Engineering, and Supplier teams to drive compliant, scalable, and efficient product and process performance.

Requirements

• Bachelor’s degree in Engineering, Science, or related technical field
• 1–2 years of experience in quality engineering, manufacturing, or validation
• Understanding of quality systems and regulatory requirements (ISO, FDA, etc.)
• Knowledge of validation processes (IQ/OQ/PQ) and statistical methods
• Familiarity with quality tools (FMEA, DOE, CAPA, Lean, Six Sigma)
• Strong analytical and data-driven decision-making ability
• Experience with technical documentation and compliance requirements
• Proficiency in Microsoft Office and data analysis tools (e.g., Excel, Minitab, JMP)
• Strong communication and cross-functional collaboration skills
• Ability to manage multiple priorities and work independently

Nice To Haves

• Experience in life sciences, pharmaceutical, or medical device industries
• Knowledge of injection molding or manufacturing processes
• ASQ certifications (CQE, Green Belt, Black Belt)

Responsibilities

• Support design, development, and product lifecycle quality activities
• Contribute to product validation and verification (IQ/OQ/PQ, V&V)
• Assist with new product introductions, including supplier selection and qualification
• Participate in root cause analysis (CAPA, SCARs) to resolve nonconformances
• Support process standardization, waste reduction, and continuous improvement initiatives
• Apply quality tools such as FMEA, DOE, Six Sigma, Lean, and statistical analysis
• Support and participate in internal, supplier, and customer audits
• Assist with supplier performance monitoring and quality improvements
• Collaborate with suppliers to ensure compliance and consistency
• Ensure compliance with ISO, FDA, and regulatory standards (ISO 9001, ISO 13485, 21 CFR Part 820, etc.)
• Support development of technical documentation (Design History Files, validation reports, product certifications)
• Contribute to maintaining robust quality systems and product quality architecture (PQA)
• Support and occasionally lead small-scale quality projects
• Collaborate with internal teams to ensure aligned, scalable, and compliant processes

Benefits

• Company-wide bonuses and long-term incentives
• 100% company-paid pension benefit
• Matching contributions to 401(k) savings plan
• Medical, dental, vision insurance
• Paid parental leave
• Family building support
• Fitness programs
• Company-paid life insurance
• Disability insurance
• Disease management programs
• Paid time off
• Employee Assistance Program (EAP)
• Recognition program

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level