Quality Engineer II - Complaints (hybrid)

Position Summary 

The Engineer II, Quality – Complaints is a product quality representative that provides hands-on technical quality engineering support to product complaint investigations for multiple manufacturing facilities. Provides guidance to the manufacturing sites Quality and Operation teams ensuring that investigation findings are appropriately addressed.  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.  The Engineer II will complete intermediate projects with guidance from more experienced engineers and managers. They gain exposure to some of the complex tasks within the job function and are occasionally directed in several aspects of the work.

Essential Duties & Responsibilities

• 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
• Conducts independent analysis and develops solutions to problems. 
• Develops approaches and designs where precedent usually exists. 
• Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design.   
• Writes detailed design specifications.
• Receives general project direction. Solicits input from more experienced engineers.
• Assists in training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
• Delivers communications tailored to the needs of the recipient (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Work on special projects as they arise

Knowledge & Skills

• 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.
• 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.
• Competent in your domain.  Familiar with other areas of domain expertise within the team.
• Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline
• Have awareness of the broader product strategy and contribute to it
• Ability to receive general project direction and solicit input from more experienced engineers.
• Requires the ability to independently make decisions that impact the attainment of project objectives.

Minimum Qualifications, Education & Experience 

• Must be at least 18 years of age
• Bachelor’s degree from an accredited college or university (Engineering, Technology, or STEM)
• 2-4 years experience
• CQE/CRE Certification desirable
• Prior experience in quality assurance is preferred. 
• Previous experience working in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required.

Work Environment

• This is largely a sedentary role. 
• This job operates in a professional office environment and routinely uses standard office equipment.
• Work is performed in a safe environment.  
• While performing the duties of this job, the employee is regularly required to work with contaminated Medical Devices in a controlled laboratory setting
•  Must be able to occasionally move objects up to 15 lbs. 
• Typically requires travel less than 5% of the time