No more applications are being accepted for this job
- Be a product expert encompassing how the product was designed, how it is manufactured, associated failure modes, and how the product is used in the field.
- Must have the ability to methodically process and investigate medical device customer complaints in a high paced, efficient, and accurate manner.
- Write effective investigation reports ensuring completion in a timely manner.
- Provide quality support and cross functional communication of customer experiences and complaint findings with the manufacturing sites.
- Liaison with Quality, Engineering, and Operations and manufacturing locations to understand ongoing CAPA investigations and product issues.
- Contacting US customers to address ongoing issues, proactively identify potential issues, and provide updates/summaries for ongoing quality initiatives impacting the customer.
- Analyze weekly and monthly trend data according to procedure to identify if there is a bias or a trend does exist.
- Working effectively in a team environment with shifting priorities and time sensitive requirements.
- Must be capable of carrying out basic standardized test methods and/or submit functional testing requests.
- A willingness and capability to work with used, and therefore contaminated Medical Devices in a controlled setting.
- Performs other functions as necessary or as assigned.
- Work on special projects as they arise.
- Ability to train/transfer knowledge to others
- Use of measurement and test equipment
- Must be a creative problem solver with the ability to troubleshoot a variety of issues
- Proficient in Microsoft Office (Excel, Word, Database) and statistical analysis programs
- Good written and verbal communications skills
- Strong knowledge of Plastic Processing and disposable Medical Device manufacturing
- Must have good mechanical aptitude
- Demonstrate ability to handle safely and competently returned contaminated medical devices.
- Must be at least 18 years of age
- Bachelor of Science in Engineering or equivalent technical degree
- CQE/CRE Certification desirable
- Experience working in a team environment successfully bringing medical device products through an FDA regulatory pathway and compliance with internal Quality Management System (QMS)
- Experience writing requirements and specification for regulated products/applications, including design traceability and verification and validation plans.
- Seven years of experience related to medical device or regulated industry
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- While performing the duties of this job, the employee is regularly required to work with contaminated Medical Devices in a controlled setting
- Must be able to occasionally move and lift objects of up to 15 pounds
- Typically requires travel 5-20% of the time
Senior Engineer, Complaints - West Valley City, United States - ICU Medical
Description
Position Summary
The Senior Quality Engineer is a product quality representative that provides hands-on technical quality engineering support to lead product complaint investigations for multiple manufacturing facilities.
This position will also have direct interaction with customers and Global Field sales reps.
Customer conference calls and visits may be conducted to better understand product issues, identify customer concerns before issues become complaints, and speak on behalf of the Quality organization.
Responsible for the accomplishment of established quality goals.Essential Duties & Responsibilities
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.