You will find our team atmosphere challenging and rewarding. In addition to working with a world-class team, receiving a competitive base salary and bonus opportunities, our U.S. employees also enjoy the following benefits: Medical, Dental, Vision, Maternity Leave, Life Insurance, Short-Term Disability, Long-Term Disability, Bereavement, 401(k) (up to 4% match with vesting from day 1), PTO, Paid Holidays, Employee Assistance Program, Education Assistance...and more! At MicroPort, we care about our employees and encourage them to make healthy lifestyle choices and embrace wellness opportunities to maintain their very best health and wellbeing.

Overall Summary

This position is responsible for evaluation of product complaints and for providing support to MPO Product Development related to complaint analysis and risk analysis. This will be accomplished utilizing knowledge in quality systems and medical device regulations while assuring compliance with MPO's Quality System and regulatory requirements.

Your duties will include:

1. Conduct the investigation, resolution, and closure of product complaints in a timely manner while facilitating efforts between Post Market Quality, Product Development, Quality Engineering, and Operations.
2. Perform trend analysis on product complaints, analyze trends, and report findings.
3. Participate in design control activities and provide input into identifying failure modes and risk assessment for new and existing products.
4. Initiate Corrective and Preventive Actions for product improvements. Participate in such teams.
5. Communicate with all groups within the organization to gather information related to product complaints, including product development, marketing, clinical, and the sales force.
6. Initiate field action evaluations and participate in field action teams.

Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

About You

We might be a great match if you have:

·       Knowledge of medical device regulations (FDA, ISO, etc.); design controls, risk management including FMEA (Failure Modes and Effects Analysis); problem solving techniques including root cause analysis; cause and effect analysis; interpretation and development of engineering specifications (including GD&T); quality improvement; complaint investigation and resolution.

·       Ability to participate on teams to complete cross-functional projects.

·       Ability to analyze complex problems and apply practical solutions.

·       Ability to prioritize multiple projects and assignments consisting of varying degrees of complexity.

·       Ability to implement and use quality tools to meet departmental goals and objectives.

·       Ability to make effective oral and written presentations.

·       Working knowledge of Microsoft office products (Word, Excel, Access, PowerPoint, and Project)

Licensure, Registration and/or Certification

Relevant professional certification such as ASQ certification as a Quality Engineer or Reliability Engineer is preferred.

YOUR EDUCATION

Required: Bachelor’s Degree in a technical field, Engineering preferred

Preferred: Master’s Degree in a technical field, Engineering preferred

YOUR EXPERIENCE

Minimum of 1-year related experience required in medical devices or related field

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities