Test Engineer II (W2T6088)

Job Title: Test Engineer II

Job Type: Onsite, Fulltime/Part-time

Location: Multiple locations

Job Description

We are seeking passionate Test Engineers to assure products, processes, and quality records conform to process standards and establish compliance within our clients’ quality system. This individual will be responsible for maintaining a strong collaborative partnership with multi-functional teams. Help facilitate success by protecting patients’ safety and meeting business needs. Involved in complaint investigation management. This will include activities pertaining to product complaints and providing information on any complaints, including evaluating data from the complaint database for our various business partners (e.g. Regulatory, Process Management).

 

Qualifications

Follows all regulations and standards for quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, engineering standards, and other governance areas as applicable. Implements and maintains the effectiveness of the Quality System. Identifies areas of risk with respect to compliance to internal and external requirements. Completes Nonconformance, Corrective Action and Preventive Action (CAPA), and complaint investigations and offers multiple solutions to issues with clear advantages and disadvantages. Influences key partners to develop and maintain Test procedures, forms, and systems. Leads meetings and communications for Test system information, concerns, and updates. Help drive standard methodologies for data trending and tracking and identification of manufacturing related complaints in alignment with Client goals. Follows U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities occasionally as assigned.

Other Desired Qualifications

• Excellent interpersonal and presentation skills for interacting with team members and clients.
• Excellent problem-solving skills.
• Excellent communication skills.

Requirements

Investigation for non-conformance Reporting into operation and manufacturing

Looking for

• Medical Cost Ratios (MCR’s)
• CAPA investigations
• Good communication
• 2-4 years of experience
• Medical device background or equivalent background
• BS/BA degree in engineering or equivalent experience

 

Application Process:

If you’re interested and available for this role and responsibilities, please go ahead and send your updated resume in a word document with your expected annual salary here.

If you are engaged in any project and not available in the job market, please feel free to share this job position within your network.