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Senior Quality Assurance Engineer
The Senior Quality Assurance (QA) Engineer actively promotes and implements the Quality Management System by means of monitoring, evaluating and reporting of all quality related activities. The intent of all Quality Assurance activities is that of compliance with all regulatory requirements and standards, customer satisfaction and continuous quality improvement. The essential functions of the QA Engineer role consist of activities in 3 main areas: Quality Management System Support, Project Quality Assurance/Quality Engineering, and Manufacturing Quality Control.
Quality Management System Support
- Maintains systems and procedures and champions the implementation of new systems and continuous improvement of systems and procedures to maintain ISO 13485 Certification.
- Reviews, approves and follows up on Engineering Changes (ECs) as required.
- Retains records per policy.
- Conducts the yearly Management Review.
- Conducts internal auditing of systems.
- Conducts CAPA activities.
- Assists with or performs training/orientation related to the Quality System.
Project Quality Assurance/Quality Engineering
- Conducts Design/Strategy initiatives in compliance with system.
- Assists with project regulatory and clinical strategies (FDA/CE, IDE, etc.)
- Reviews/assists with the preparation of Market and Product Specifications, Review Drawings, manufacturing procedures, and test procedures.
- Monitors and supports supplier related activities, including evaluation/auditing, qualification, performance rating, corrective actions, etc.
- Assists with the preparation of regulatory submissions.
- Assists in mitigating project risks.
- Conducts Design Review.
Manufacturing Quality Control
- Monitors all Quality related activities in the following areas: Incoming Inspection, Manufacturing, In-process Inspection, Final Inspection, Calibration, Preventive Maintenance, finished goods release/Distribution tracking, Returned Material Activity (RMAs) and Complaints.
- Reviews completed MRR, TRV for compliance with documentation, traceability, training and calibration requirements.
- Conducts nonconforming material investigations.
- Provides QA support (reviews & analyzes data, conducts experiments, provides disposition) on problems in manufacturing and test areas.
DESIRED SKILLS AND EXPERIENCE
A bachelor’s degree in Engineering or related discipline and 4-7 years of experience in a Medical Device Quality Assurance or related field (e.g. product development); OR a master’s degree and 2 – 4 years related experience; OR an equivalent combination of education and experience is required.
In addition, should possess:
- Logical thinking and problem-solving skills as well as a high level of creativity;
- Knowledge in the use of basic computer software, including MS Office;
- A thorough understanding of the QSR and ISO regulatory environments;
- Excellent organizational and time management skills including the ability to prioritize/ understand how to deal with many conflicting priorities;
- The ability to work independently;
- Excellent verbal and written communication skills.