Quality Engineer | Aved

Lithion Battery INC•Billerica, MA

5h•Onsite

About The Position

Reporting to the Director of Quality, the Quality Engineer, with limited supervision, is responsible for developing, managing, maintaining, and improving processes that ensure product and process compliance. This includes ensuring that all customer specifications, relevant industry, and regulatory standards have been met and satisfied. This role supports the planning, coordination, and execution of assigned quality deliverables in a highly regulated environment, requiring complex problem-solving skills. The Quality Engineer plays a key role in sustaining the Quality Management System, ensuring product compliance, and driving continual improvement, contributing to Aved’s goal of operational excellence.

Requirements

2–4 years of experience in a manufacturing environment
Familiarity with ISO 9001, ISO 13485 standards and procedures
Working knowledge of Microsoft Office (Excel, Word, PowerPoint, Visio)
Proficient in measurement and visual inspection techniques
Strong statistical data analysis skills.
Highly organized, complex problem solving, detail-oriented, and capable of prioritizing tasks with limited supervision.
Able to meet deadlines under pressure in a fast-paced environment
Able to follow established policies and procedures
Must be fluent in reading, writing, and speaking English.

Nice To Haves

Minitab proficiency
Validation knowledge for IQ, OQ, and PQ (ISO 9001)
ISO 9001 auditing experience or certification
Familiarity with battery cell manufacturing

Responsibilities

Facilitate in the creation, maintenance and continual improvement of: product work instructions, standard operating procedures (SOPs), Process Flows, Control Plans, PFMEAs, Bubble Prints, First Article Inspection Reports, and mentoring of the Aved production team in quality assurance best practices.
Primary customer facing focal point for executing customer product validation. In partnership with Operations Engineering drives the IQ/OQ/PQ and/or PPAP processes to completion.
Lead CAPA investigations, both internal and external, using structured methodologies such as: 8D, 3-Legged 5 Whys, Ishikawa/Fishbone, Pareto Analysis .....
Assist with incoming inspections, equipment calibrations, line validations, and process audits to ensure compliance with specifications, standards, and regulations.
Identify opportunities for improvement and collaborate with cross-functional teams to implement continuous improvement initiatives.
Monitor process deviations, ensure corrective and preventive actions are implemented, and review process changes for compliance.
Analyze quality metrics and prepare reports that summarize findings and provide actionable insights.
Communicate findings and recommendations to management to drive defect reduction and process enhancements.
Lead and facilitate the review and disposition of nonconforming materials through Material Review Boards (MRB).
Perform other related duties as assigned.