Experience Required: 4-10 years in medical device Quality Assurance / Design Controls
Reports to: CEO
Job Summary
The primary responsibility of this position is to advise and implement quality systems for medical device manufacturers. This position requires utilization of Quality Management System methods, including but not limited to: quality system implementation, project management, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities. Must interact with consultants, clients, suppliers, and experts outside QA Consulting in order to communicate and implement QA Consulting’s objectives.
Principal Duties and Responsibilities
Fulfill Project Manager role for a distinct set of clients by serving as primary client contact within QA Consulting, translating client needs into a defined scope of work, and working with QA Consulting staff to delegate and effectively complete client deliverables
Implement processes and procedures and conduct analyses to sustain and improve the Quality Management Systems of QA Consulting’s clients. Examples include risk planning, analysis, design controls, verification and validation, and inspection methods and procedures
Responsible for defining production and inspection methods, monitoring performance, and handling nonconformances
Conduct post-market activities including complaints handling, MDR evaluations, and CAPA assessments
Responsible for effectively communicating with client, meeting client deadlines, and managing client expectations
Supporting Top Management and consulting group in the development and implementation of client objectives
Use creative problem-solving skills to identify, solve, and/or improve process anomalies
Perform engineering research, statistical analysis, write technical protocols/ reports using relevant standards and data
Work with suppliers, laboratories, clients, and other group members to assist with implementation and effectiveness of client deliverables
Work with Quality Specialists to generate and release Engineering Change Notices and implement document controls
Review prints, data, procedures, and test protocols/ reports for accuracy and technical application of standards (ISO, AAMI, ASTM, and IEC) for electromechanical systems
This is not an exhaustive list of duties or functions
Knowledge, Skills, and Abilities
Must demonstrate competence in the medical device quality system regulations 21 CFR 820 and ISO 13485
Able to apply quality tools techniques such as: design controls, quality system auditing, inspection methods, statistical sampling plans, gauging studies, design verification and validation, and process validation
Ability to apply mathematical concepts such as statistical inference and probability
Ability to apply logic, creativity, and scientific thinking to a wide range of intellectual and practical problems
Must have experience working with multiple sized companies, from start-up through fortune 500 firms
Time management and communication both to QA consultants and the client
Demonstrates ownership for the integrity of work
Able to work independently and consider options for completing work
Strong written and verbal communication skills
Working knowledge of FDA regulatory premarket notification processes and labeling requirements
Must be able to manage projects and work with team members to complete tasks on time and within budget
Education
Bachelor’s degree in Engineering (Biomedical, Mechanical, or Electrical) is preferred. Other scientific disciplines will be considered
Master’s degree in Engineering Management or MBA preferred
ASQ Certification as a Quality Engineer, ASQ Certified Reliability Engineer, or ASQ Manager of Quality/Organizational Excellence is desired
Internal Number: JD-008
About QA Consulting, Inc.
QA Consulting has an impressive team of experts specializing in: regulatory affairs, quality management system implementation and maintenance, training, and microbiology services.
QA Consulting holds ISO 13485 certification, is a WBENC-Certified Women's Business Enterprise, and is certified by the state of Texas as a historically underutilized business (HUB).
