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Quality Engineering Consultant

Company:
Leon s Furniture Limited
Location:
Medinipur, West Bengal, India
Salary:
$10,500.00USD
Posted:
September 16, 2017
Description:

Dear Candidate,

Greetings from LEON'S FURNITURE LTD. Leon is looking for a super talented Quality Engineering Consultant to join our Leon'e Furniture Ltd team. A detail oriented person with a versatile approach, as the projects tend to vary.

Position Details

Title: Quality Engineering Consultant

Location: Quebec, Canada

Job Type: Full-time

Travel: Up to 25%

Experience Required: 4-10 years in medical device Quality Assurance / Design Controls

Reports to: Design Manager

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 CFR820 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 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

Characteristics

Deadline driven

Able to work efficiently, independently, and as part of collaborative team

COMPENSATION:

Compensation will be based on experience and qualifications. Benefits include paid vacation, 401(k) plan, group medical insurance, long

term disability insurance, life insurance and employee discounts on product.

TO APPLY:

All applications are appreciated; however, please note, only those candidates selected for an email online interview will be contacted.

Please email your resume using Quality Engineering Consultant in the subject line.