The Quality Engineer is a key technical role responsible for ensuring all aspects of overall product quality with strong focus on overseeing product transfer from development to manufacturing and continuous product/process quality improvement in manufacturing. The QE will work to make improvements to the company quality system. The position requires interaction with all levels of Management. Engineering and Manufacturing along with interactions with external entities including contractors, suppliers, and customers.
Conduct inspection to ensure product quality is present at incoming, in-process, and at final inspection. Establish inspection procedures and provide guidance in inspection methodology. Provide technical oversight to the manufacturing group.
Provide technical expertise to members of the engineering and manufacturing teams. Oversee the MRB evaluation process. Represent QA on cross-function MRB committee.
Interpret quality data and non-conformances. Perform failure evaluations, determine root cause, and implement corrective action. Verify the corrective actions.
Initiate and/or participate in cross-functional teams to support company goals. Lead product quality related meetings; follow-up with team members for updates and actions; and distribute meeting minutes.
Working with Design & Manufacturing Engineering, establish minimum acceptable requirements for the selection of qualified suppliers.
Assess supplier capabilities through direct visits, technical discussions and quality system assessments. Communicate quality issues to suppliers as needed and provides assistance to develop corrective actions.
Identify, establish, analyze, and maintain Quality Metrics and report to management. Identify areas for improvement and help lead continuous improvement efforts.
Collaborate with development and manufacturing personnel in writing and / or reviewing design verification and validation reports.
Review and approve records, documents and SOPs to ensure conformance with the regulations and guidelines. Assist in managing document control activities.
Lead complaint or CAPA investigations; and contribute to product or process risk analyses as needed.
Assist in the internal audit program to help ensure the compliance of the internal departments to applicable regulations. This may include leading internal audits after training.
Behavioral and Interpersonal:
Excellent organizational skills
Ability to work independently or under minimal supervision
Ability to communicate efficiently and effectively cross functionally with departments such as Manufacturing and Engineering and present information to top management and auditors from various compliance agencies.
Working knowledge of statistical principles and applications; qualitative and quantitative data analysis; DOE, Acceptance and Sampling; process improvement/optimization; gage R&R, measuring systems and equipment including hand tools and 3 dimension vision systems; and system and product audit.
Knowledge of Microsoft Word and Microsoft Excel
Knowledge of ISO standards for Class III medical devices preferable (ISO 13485, 14971)
Ability to read, analyze and interpret international and national Quality standards.
Working knowledge of statistical programs (Minitab or other statistical packages)
Understanding of manufacturing processes, challenges, and solutions
Proficient in manufacturing and quality documentation development
Up to 20% Travel
Education and Experience Requirements:
Bachelor’s degree in Electrical, Mechanical, Industrial or Manufacturing Engineering preferred.
Minimum two (2) years of experience in quality, product development or process development within FDA and/or ISO 13485 regulated medical device setting, with hands on knowledge of regulations with minimum of three (3) years in quality is required. Experience in medical devices manufacturing; experience with catheter manufacturing highly preferred.
Thermedical® is developing a proprietary thermal ablation therapy that can treat significantly larger tissue volumes using a single device than conventional technology. The Company is focused on the treatment and cure of Ventricular Tachycardia (VT), an irregular heartbeat that can lead to sudden cardiac arrest, and the treatment of soft tissue conditions.
Thermedical® is a privately held medical device company based in Waltham, Massachusetts.