SUMMARY: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. Compliance 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. Complex problem solving skills and techniques are a must and will be challenged on a daily basis.
The Quality Engineer plays a key role in sustaining the Quality Management System, ensuring product compliance, and driving continual improvement. The Quality Engineer is a key team member in Aved's goal of operational excellence.
DIRECT REPORTS:KEY RESPONSIBILITIES & DUTIES: - 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.
QUALIFICATIONS & COMPENTENCIES:- 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. Minitab proficiency a plus.
- 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
- Preferred but not required:
- Validation knowledge for IQ, OQ, and PQ (ISO 9001)
- ISO 9001 auditing experience or certification
- Familiarity with battery cell manufacturing
- Must be fluent in reading, writing, and speaking English.
WORK ENVIRONMENT & PHYSICAL REQUIREMENTS:This role requires working in both office and manufacturing settings, with the following physical and environmental demands:
- Prolonged sitting at a desk or workstation
- Repetitive hand and arm movements
- Ability to lift and carry up to 50 lbs., including tools and materials
- Frequent reaching, grasping, bending, pushing, pulling, and twisting motions
- Standing and walking for extended periods during inspections or production support
- Occasional kneeling or bending to perform detailed assessments
- Occasional travel to customer sites or other facilities may be required
- Ability to respond quickly in urgent situations, including equipment or process troubleshooting
- Exposure to temperature variations, noise, and potential contact with battery chemicals or materials
- Use of PPE such as safety glasses and gloves, as required by safety protocols
