GENERAL

The Principal QA Engineer shall actively promote and implement the Quality Management System by means of monitoring, evaluating and reporting of all quality related activities. The intent of all Quality Assurance activities shall be that of compliance with all regulatory requirements and standards, customer satisfaction and continuous quality improvement. The essential functions of the Principal Quality Assurance Engineer position consist of activities in 3 main categories: Quality Management System Support, Project Quality Assurance/Quality Engineering, and Manufacturing Quality Control.

ESSENTIAL FUNCTIONS

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.

Doc control:

Reviews, approves and follows up on Engineering Changes (ECs), as required;
Conducts records retention per policy.
Conducts yearly Management Review.
Conducts Internal Auditing of systems.
Conducts CAPA activities:
Determines root cause, evaluates and implements preventive and corrective actions for quality problems;
Monitors and reports on the effectiveness of internal and external corrective and preventive action activities.

Conducts Training/Orientation activities:

Assists with or performs training/orientation related to the Quality System.

Project Quality Assurance/Quality Engineering

Design/Strategy:

Reviews/prepares project documents/strategies in compliance with system (Design and development plans, etc.);

Assists with project regulatory and clinical strategies:

FDA/CE, etc.
IDE
Development:
Reviews/assists with the preparation of Market Spec and Product Spec, Review Drawings, manufacturing procedures, and test procedures:
Confirms compliance of specifications with international standards;
Confirms complete/sufficient rationale/justification for Specs/Test method;
Confirms specifications developed to address user/device/process risk;
Evaluates the need for inspection points in manufacturing process flow and writes inspection procedures.
Monitors and supports supplier related activities, including evaluation/auditing, qualification, performance rating, corrective actions, etc.
Assists with the preparation of regulatory submissions:
510(k)
Technical File

Risk management:

Creates or assists in the creation of UFMEA, DFMEA, PFMEA.
Product/Process Verification/Validation:
Confirms DV/V testing addresses all Market Spec and Product Spec requirements to appropriate sample sizes;
Assists with IQ/POQ/PQ/PPQ strategy/execution.

Design Review:

Represents Quality Assurance in design review of new and redesigned products.

Manufacturing Quality Control

Monitors all Quality Assurance 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, calibration requirements.
Nonconforming material investigations:
Initiates action to prevent the occurrence of any non-conformities relating to product, processes and the Quality Management System;
Identifies, records and follows-up on problems relating to products, processes and the Quality Management System and provides, and verifies the implementation of, solutions to eliminate recurrence;
Controls further processing, delivery or installation of non-conforming products or services until the deficiency or unsatisfactory condition has been corrected.
Provides Quality Assurance support (review & analyze data, conduct experiments, provide disposition) on problems in manufacturing and test areas.

DESIRED KNOWLEDGE, SKILLS AND ABILITIES

A bachelor’s degree in Engineering and 7+ years of experience in a Medical Device Quality Assurance or related field (e.g. product development); OR a master’s degree and 4 - 7 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.

Naglreiter MDDO