Development Quality Engineer - Onsite

Job Description

Development Quality Engineer - Onsite

• COntract Duration 12+ year

• Our client is seeking an experienced, high caliber Development Quality Engineer. This position assures new or modified products conform to quality standards and establishes compliance with the quality system.
• Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
• Each employee can make a difference at Client and has the power, either individually or as a team, to influence the success of the company.
• Our cient is team-oriented, fast-paced and progressive.
• Our client value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

• The Development Quality Engineer performs Failure investigations of CRM product returns
• Document and generate failure analysis reports in the Complaint Handling System.
• Support CAPAs in the Corrective Action System
• Provide feedback and background information of returned product investigations to the Customer Quality Support Group and to Postmarket Surveillance
• Support internal & external audit responses
• Complete Document Change Request Reviews in a timely and objective manner.
• Additional duties may be identified by functional management based on the current project/business objectives
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with 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, on occasion, as assigned

• Bachelor level degree in Electrical Engineering or Biomedical field required
• 0-2 years' experience - Solid communication and interpersonal skills
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to travel approximately 10%, including internationally
• Ability to maintain regular and predictable attendance
• Previous engineering experience preferred
• Experience working in a broader enterprise/cross-division business unit model preferred

• Our client is a globally diversified healthcare company with a central purpose to help people live their healthiest possible lives. They offer a broad portfolio of market-leading products that align with favorable long-term healthcare trends in both developed and developing markets. Working with this company, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges while experiencing myriad cultures, geographies, and technologies. They are creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. It serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products, and branded generic medicines.
• If you are looking for a great company to work for, look no further because our client has received an average of a four-star rating from its thousands of employees that have written positive reviews on Glassdoor and Indeed.